Pain is one of the most common reasons for visiting a physician. Although
there are a wide range of treatments now available, new approaches are being
investigated. At Beth Israel Medical Center's Department of Pain Medicine
and Palliative Care, studies are currently recruiting patients with some types
of neuropathic pain, pain due to cancer, low back pain, and pain associated
with multiple sclerosis and osteoarthritis.
Neuropathic pain includes many conditions caused by injury to nerves. The
discomfort experienced by patients with this type of pain can be severe, long-lasting,
and not easily treated by current analgesics.
Clinical trials are also currently underway to study postherpetic neuralgia,
fatigue in cancer and AIDS, the micronutrient L-carnitine, and treatments
for breakthrough pain. New methods of structuring doctor-patient relationships
are also being investigated, as well as the development of strategies
to increase access to pain specialists in the United States.
For more information write or call
Jeanne A. Lapin, RN
Department of Pain Medicine and Palliative Care
Institute for Education and Research
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Phone: (212) 844-1475
Email: stoppain@chpnet.org
Breakthrough Pain in Patients with Cancer
IRB #213-05 A Double-Blind, Randomized, Placebo-Controlled,
Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients Followed
by an up to 12-Month Non-Randomized, Open-Label Extension to Assess Long-Term
Safety - Protocol EN3267-005
Principal Investigator: Russell K. Portenoy,
MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: Endo Pharmaceuticals Inc. is conducting
a research study of an experimental drug called EN3267 as a therapy
in the management of breakthrough pain (intermittent or irregular flares
of pain that can occur suddenly). The study drug, EN3267, is the drug
fentanyl citrate. Subjects will be instructed to place the study medication
under the tongue and allow it to dissolve. The medication should dissolve
completely in approximately 1 minute. This dosing method of fentanyl
is a new investigational preparation.
The purpose of this study is to compare the effectiveness (the power
to produce an effect) of EN3267 with that of placebo (inactive substance
or “sugar pill”) in treating breakthrough pain episodes
in subjects with cancer.
The first part of the study begins with a titration of EN3267 (methods
of increasing the study drug that a study participant will take until
a dose is reached that best works for his/her breakthrough pain). Every
participant will receive EN3267 during this study period. Once a dose
has been identified as an adequate treatment for their breakthrough
pain, subjects will enter the double-blind part of the study. In the
double-blind part, they will be assigned by chance, to get either EN3267
or placebo (a look-alike with no active ingredients, sometimes called
a sugar pill) during the treatment period of the study.
The second part of the study is an open-label, long-term extension
period. Subjects who complete the double-blind period may continue to
use EN3267 to treat breakthrough pain episodes over a 12-month period.
Participation will involve approximately 13 months with up to 18 separate
visits at the site.
Breakthrough Pain in Patients with Cancer
IRB #214-05 A Multiple-Dose, Non-Randomized,
Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness
of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients - Protocol
EN3267-007 Principal Investigator: Russell
K. Portenoy, MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: EN3267, a rapidly dissolving tablet
formulation of fentanyl citrate, is currently under development for
the treatment of breakthrough cancer pain in patients already receiving
an opioid (narcotic) medication for pain. This formulation of fentanyl
is designed specifically to be placed under the tongue and allowed to
dissolve. The medication should dissolve completely in approximately
1 minute. This dosing method of fentanyl is a new investigational preparation.
Eligible study participants will begin a titration of EN3267 (methods
of increasing EN3267 that study participants will take until a dose
is reached that best works for their breakthrough pain). Every participant
will receive EN3267 during this study period.
Once a dose has been identified as an adequate treatment for their
breakthrough pain, subjects will be able to receive EN3267 for up to
12 months to treat breakthrough pain episodes. Patients will return
to the study site each month.
Safety and effectiveness of EN3267 will be assessed throughout the
12 months.
Breakthrough Pain in Patients with Cancer
IRB #237-05 A Double-Blind, Placebo Controlled,
Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl
in the Treatment of Breakthrough Pain in Cancer Subjects - Protocol
FEN-201
Principal Investigator: Russell K. Portenoy,
MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: Subjects with chronic cancer-related
pain often experience episodes of pain, called “breakthrough”
pain. Breakthrough pain occurs between doses of regularly scheduled
(around-the-clock), long-acting pain medication.
BioDelivery Sciences International, Inc. has developed a small disc
containing fentanyl which is placed on the inside of the cheek. The
purpose of this study is to determine if BioErodible MucoAdhesive fentanyl
(BEMA™ fentanyl) is safe and effective in the treatment of breakthrough
pain in cancer subjects.
Subjects with chronic cancer-related pain, having frequent episodes
of breakthrough pain, will enter the titration phase of the study. During
this portion of the study, the best dose of BEMA™ fentanyl to
control the breakthrough pain will be determined for each subject. Once
a subject’s effective dose is determined, the subject will then
enter the randomized portion of the study. All eligible subjects will
then receive 9 doses of the study medication. The dose of BEMA™
fentanyl will be the same dose determined to be effective for each subject
during the titration period. Three of the discs will be placebo (a dummy
treatment that contains no active ingredients) and 6 will contain fentanyl.
The order in which the study drug (BEMA™ fentanyl or placebo)
is given will be randomized. In this study, randomized means the 9 discs
will be administered in a mixed-up order so that neither the subject
nor the doctor will know if the disc is fentanyl or placebo (this is
referred to as ‘double-blind’).
Males and non-pregnant females over the age of 18 years, who are receiving
the equivalent of 60 – 1000 mg oral morphine per day for chronic
cancer-related pain and are experiencing at least one episode of breakthrough
pain per day, will be eligible to participate.
The duration of the study is 29 days and consists of 4 clinic visits.
Breakthrough Pain in Patients with Cancer
IRB #238-05 An Open Label, Long-Term Treatment
Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough
Pain in Cancer Subjects on Chronic Opioid Therapy - Protocol FEN-202
Principal Investigator: Russell K. Portenoy,
MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: BioDelivery Sciences International,
Inc. has developed a small disc containing fentanyl which is placed
on the inside of the cheek. The purpose of this study is to determine
if BioErodible MucoAdhesive fentanyl (BEMA™ fentanyl) is safe
and effective in the treatment of breakthrough pain in cancer subjects.
The study will continue for an unlimited period of time and consists
of monthly clinic visits. Open label means
that all subjects will receive the active study drug BEMA™ fentanyl
and that both the subject and the study physician will know the dose
that is being prescribed.
Subjects are eligible to enter following successful completion of the
previous study, FEN-201 (IRB #237-05), and will be able to continue
on the effective dose used in that study with dose adjustments as needed.
In addition, other subjects with chronic cancer-related pain that experience
frequent episodes of acute (breakthrough) pain can also be enrolled
in this study.
The subject and the study doctor will identify, ahead of time, a specific
type of breakthrough pain (“target episodes”) that will
be treated with BEMA™ fentanyl. In the titration phase of the
study, the best dose of BEMA™ fentanyl to control the breakthrough
pain will be determined for each subject. Once the dose is determined,
subjects will then enter the open-label phase of the study where they
will take BEMA™ fentanyl for breakthrough pain.
Participating subjects will be asked to visit the study doctor up to
3 times during the first 2 weeks to establish their required dose of
BEMA™ fentanyl. After that, they will be required to visit the
study doctor every 4 weeks for as long as they continue in the study.
The first visit will take approximately 1-2 hours.
Breakthrough Pain in Patients with Chronic
Pain
IRB# 131-06 A 12-Week Open-Label Study
with 3 Within-Patient Double-Blind Placebo-Controlled Periods to Evaluate
the Efficacy and Safety of ORAVESCENT® Fentanyl Citrate Treatment
for the Management of Breakthrough Pain in Opioid-Tolerant Patients
with Noncancer-Related Chronic Pain
Principal Investigator: Russell K. Portenoy,
MD
Contact: Andrew Kobets 212-844-1491 or
Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: The study drug, OraVescent®
fentanyl citrate, is an investigational drug (a new compound), that
has not yet been approved by the U.S. Food and Drug Administration (FDA).
It is being studied as a therapy in the management of breakthrough pain
(intermittent or irregular flares of pain) in patients with chronic
(long-term) pain.
Included in the study will be adult subjects 18 through 80 years of
age who have chronic pain (i.e., pain is of at least 3 months duration)
that is associated with any of the following conditions: back pain,
neck pain, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic
injury, complex regional pain syndrome, fibromyalgia, osteoarthritis,
and chronic pancreatitis. Patients with other chronic painful conditions
may qualify for the study with permission from the Sponsor, Cephalon,
Inc.
OraVescent® fentanyl citrate is a newly designed tablet that releases
a drug called fentanyl citrate into the body. To administer the medication,
the tablet is placed in the mouth between the cheek and gum, and allowed
to dissolve (about 10 minutes).
The study begins with all subjects receiving ORAVESCENT® fentanyl
to be used to determine, through titration, each person’s successful
dose. The dose of ORAVESCENT® fentanyl identified to be successful
is defined as a single dose that provides adequate analgesia for that
person without unacceptable adverse events. Subjects will then be treated
with open-label ORAVESCENT® fentanyl for 4 weeks, followed by a
double-blind treatment period (treating 9 breakthrough pain episodes)
to assess the effectiveness of ORAVESCENT® fentanyl compared to
placebo (tablets that look like ORAVESCENT® fentanyl but have no
active ingredient). This cycle will be repeated twice.
All subjects will return for 9 clinic visits to assess safety and tolerability.
The need to adjust the dose of the study medication during the study
will be taken into account.
Eligible subjects will be compensated for their time and travel expense
required to participate in the study.
Daytime Sleepiness Due to Opioid Therapy
IRB #060-06 A Double-Blind, Randomized,
Placebo-Controlled Study of Modafinil and Morphine in Patients with
Excessive Daytime Sleepiness Due to Opioid Therapy
Principal Investigator: Russell K. Portenoy,
MD
Contact: Andrew Kobets 212-844-1491 or
Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: Medgenex, Inc. is conducting a research
study with a drug called modafinil as a therapy in the management of
daytime sleepiness. The purpose of this research study is to evaluate
how well modafinil will decrease the sleepiness that may occur throughout
the day when persons are taking opioid (narcotic) pain medications such
as morphine. The Food and Drug Administration (FDA) has not approved
this drug for treating daytime sleepiness caused by opioid (narcotic)
pain medications, and so for that reason, it is considered to be investigational.
Modafinil is currently approved by the FDA for other disorders that affect
sleeping habits.
The study will enroll subjects ages 18 and older with moderate to severe
chronic pain who are receiving a stable, oral opioid regimen equivalent
to 30 to 800 mg of oral morphine per day and who have been on opioid
therapy for at least 3 months. Eligibility criteria include only those
patients who have been identified as having excessive daytime sleepiness.
Eligible subjects will be “randomized” into one of three
groups. Randomized means that a subject is
put into a group by chance, much like flipping a coin. Subjects will
receive either the study drug (modafinil 200 mg or modafinil 400 mg)
or placebo (like a sugar pill without active drug) once a day at approximately
8:00 AM in the morning.
This is a double-blind study. That means
that neither the subject nor the study investigator will know which
study drug the subject will receive. The reason for not knowing if the
subject is taking the study drug or the placebo is to test the effects
of the drug in a way that will not be influenced by anyone’s opinions
or expectations.
The study will last for no longer than 8 weeks. Once the subject begins
to take the study drug, treatment will continue for 4 weeks. Subjects
will be asked to return to the study clinic several times during the
study. These clinic visits will last about one hour.
Eligible subjects will be compensated for their time and travel expense
required to participate in the study.
Fatigue in Patients with Cancer
IRB #175-04 Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients with Cancer - Protocol E4Z02
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Ella Dvorkin, MSW, CSW, (212)
844-1483
Status: Open for Enrollment
Design: This study is being funded by a grant
from the Eastern Cooperative Oncology Group (ECOG). ECOG is a cancer
group that conducts studies for the National Cancer Institute. The study
doctor is a member of ECOG.
The purpose of this study is to determine whether L-carnitine supplementation
will improve fatigue and related phenomena in subjects with cancer.
Adult subjects with a diagnosis of cancer and significant persistent
fatigue at the time of the screening interview will be evaluated for
eligibility.
In the study phase, patients will receive either the study drug (L-carnitine)
or a placebo. The doses of study drug and placebo will be titrated over
2 days to the desired study dose. This phase will last for 4 weeks.
In the following extension phase, which will continue for an additional
4 weeks, all the patients enrolled in the study will receive L-carnitine.
The extension phase will ensure that patients who originally received
placebo have the opportunity to receive a potentially beneficial drug.
Subjects may consent to have an additional tube of blood collected
before they start treatment and during their Week 4 evaluation. Researchers
hope these blood tests will help them learn more about cancer and other
diseases.
Headache
IRB #036-06 Evaluation of Response to Treatment,
Quality of Life, and Aberrant Behavior in Patients Receiving Opioids
for Headaches. A Case Series
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Jeanne Lapin, RN, 212-844-1475
Status: Open for Enrollment
Design: This is a case series to determine
the response to opioid treatment, aberrant behavior, and quality of
life of patients with headaches currently under the care of a physician
in the Department of Pain Medicine and Palliative Care.
Active patients will be grouped by different types of headache following
the guidelines of the International Association for Headaches, obtaining
the information from patient interview and medical records. Questionnaires
will help to confirm the type of headache, determine the types of medications
that patients are taking, assess quality of life, frequency and severity
of headaches, visits to the emergency room, and the presence or absence
of aberrant behavior.
Improving Quality of Care
IRB #130-03 Rethinking Doctor-Patient Relationships
Principal Investigator: Russell K. Portenoy,
MD
Contact: Michael Yedidia, PhD, 212-998-7447
Status: Open for Enrollment
Design: New methods of structuring doctor-patient
relationships will be investigated in this research project with the intent
to promote patient-centered care. The study will consist of a structured
interview. The responses from participants will contribute to recommendations
for a new training process for physicians, preparing them to assume new
roles in relationships with patients so as to improve the quality of care.
Subjects will be systematically selected to include individuals from a
variety of settings and socio-demographic groups in order to capture diverse
views; women and minority patients and providers will be over-sampled whenever
possible. All respondents will be over the age of 21. Other criteria for
inclusion are that subjects converse easily in English and that they are
sufficiently alert to discuss the topics addressed in the study.
The study is being conducted by Dr. Michael Yedidia, a faculty member at
the Wagner Graduate School of Public Service at New York University in collaboration
with Department of Pain Medicine and Palliative Care at Beth Israel Medical
Center.
L-Carnitine in
Patients with AIDS
IRB #098-02 Phase II Developmental Study
on Fatigue in AIDS Patients
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Ella Dvorkin, MSW, CSW, (212)-844-1483
Status: Open for Enrollment
Design: Fatigue is a commonly reported symptom
in patients with AIDS placing them at risk for micronutrient deficiencies
because of decreased caloric intake, increased metabolic requirements, and
treatment with medications that can interfere with its absorption, synthesis,
and excretion.
In the present study, L-carnitine is used to treat patients with carnitine
deficiency, fatigue, and Stage IV-C AIDS. This study is being funded by
a grant from the Nation Institutes of Health (NIH).
Patients are randomized to receive oral L-carnitine or a suitable placebo,
2 times/day, over a 2-week period in double-blind fashion. A dose titration
will be used to decrease the possibility of adverse effects. Questionnaires
to assess fatigue, performance status, cognitive function, mood, and quality
of life are completed at baseline and at specific intervals. At Week 3,
all patients will be supplemented with a standard dose of L-carnitine.
No major risks are anticipated from the administration of this dietary supplement.
Long term oral administration of L-carnitine may cause mild gastrointestinal
symptoms that include nausea and vomiting, abdominal cramps and diarrhea.
The total duration of the study will be 5 weeks and will include a total of
four study visits.
Low Back Pain Study
IRB #106-03 A Pilot Trial of IV Pamidronate for
Low Back Pain
Principal Investigator: Marco Pappagallo,
MD
Contact: Brenda Breuer, PhD, (212) 844-1290
Status: Open for Enrollment
Design: This is a single center, randomized,
double-blind, placebo-controlled dose escalation pilot study. The primary
objective is to determine which pamidronate treatment protocol is optimal
for the Phase III trial.
Pamidronate belongs to a class of drugs used to treat weak or brittle bones.
The purpose of this research study is to evaluate the effect of pamidronate
on chronic low back pain. While preliminary results with pamidronate for
low back pain are promising, well-designed trials are needed to determine
the true effectiveness of this drug for low back pain.
Study subjects will receive intravenously (injection into a vein) administered
placebo or pamidronate. There will be very close monitoring via blood tests,
physical examinations, and telephone contact with subjects.
Eligible participants include males and females over age 21, with non-cancer-related
low back pain that has been present for at least 3 months.
Risks associated with pamidronate include flu-like symptoms within 3 days
of the treatment. The development of local inflammation of a vein, increased
bleeding from low platelets, and low blood calcium or magnesium levels is
rare.
Neuropathic Pain
IRB #104-03 Pharmacokinetics-Pharmacodynamics
Study of Levetiracetam in Patients with Neuropathic Pain: A Two-Phase 'Enriched
Enrollment' Design Including A Randomized Crossover Study
Principal Investigator: Ricardo Cruciani,
MD, Ph.D.
New Contact: Helena Knotkova, PhD, (212)
420-3823
Status: Open for Enrollment.
Design: Levetiracetam is a drug approved by
the U.S. Food and Drug Administration (FDA) for the treatment of epilepsy.
Research data suggest that it may be useful in the treatment of neuropathic
pain (pain caused by nerve damage). The purpose of this research study is
to evaluate the safety and efficacy (ability to decrease pain) of levetiracetam
for the treatment of neuropathic pain. Levetiracetam is not currently approved
by the FDA for the treatment of pain and is, therefore, considered experimental.
Patients with a diagnosis of neuropathic pain will be considered for study.
Examples of neuropathic pain include diabetic neuropathy (DN), toxic neuropathy,
HIV neuropathy, post-herpetic neuralgia (PHN), post-stroke pain, and complex
regional pain syndrome (CRPS).
This is a two-phase study designed to assess the efficacy and safety of levetiracetam
to treat neuropathic pain. The first phase is an open-label trial of levetiracetam
at escalating doses, for a maximum duration of 12 days. Subjects who respond
to levetiracetam (decreased daily 'pain on average') will be enrolled in the
second phase. In this second phase, subjects will receive either the study
drug (levetiracetam) or a placebo tablet (a tablet that does not contain any
active drug). Each period includes a there-day baseline period, maximum 12
days of drug titration and one maintenance week. One week of medication tapering
and one week off study medication will separate the two periods.
The maximum duration of the study is 66 days.
Painful Conditions of the Wrist
IRB #092-05 A Study of the Effectiveness and
Safety of the Carpal-Ease Unit for the Treatment of Wrist Pain
Principal Investigator: Peter Homel, PhD
Contact: Peter Homel, PhD, (212) 844-1490
Status: Open for Enrollment
Design: This is a research study of an experimental
device called Carpal-Ease as a therapy in the management of painful conditions
of the wrist. The Carpal-Ease unit is investigational, which means that it
has not received marketing approval from the U.S. Food and Drug Administration
(FDA).
This research study is being done to see if the Carpal-Ease unit is an effective
treatment for wrist pain due to carpal tunnel syndrome, wrist arthritis or
wrist repetitive stress syndrome. The study will compare the active treatment,
when the Carpal-Ease unit is turned on, to a placebo (when the unit is turned
off).
The Carpal-Ease unit is a newly designed system that uses a low voltage electrical
energy to encourage the flow of excess fluid (swelling) inside the carpal
tunnel to flow outward. The result relieves pressure on the median nerve,
which in turn leads to reduction in pain and greater ease of movement.
The study will take place over four weeks.
Painful Oral Mucositis
IRB #261-04 A Study of the Feasibility
of Avinza Administered via Gastric Tube for Treatment of Pain in Head
and Neck Cancer Patients Undergoing Radiation Therapy
Principal Investigator: Russell K. Portenoy,
MD
Contact: Lorraine Manco, RN, 212-844-1481
Status: Open for Enrollment
Design: Avinza is a 24-hour formulation of morphine
sulfate and has been approved by the U.S. Food and Drug Administration
(FDA) to treat chronic pain in patients who need around the clock therapy
for an extended period of time. In this study, the Avinza capsule will
be opened and the contents given through a gastric (stomach) tube. The
way that Avinza will be given in this study is experimental.
Avinza is a long acting morphine formulation that is intended for ‘once
a day’ dosing. It comes in a capsule containing two forms of morphine.
One is for immediate release in order to provide immediate relief of
pain. The other is for extended release over the course of 24 hours
to maintain steady pain relief over time. The purpose of this research
study is to evaluate the safety and effectiveness of Avinza when given
once a day by way of a gastric tube in patients receiving radiation
therapy as treatment for head and neck cancer. In this study, all patients
will receive the active study medication, Avinza.
Adult patients between 18 and 65 years of age and currently receiving
radiation therapy for the treatment of head and neck cancer will be
considered for study. Eligible patients will qualify for the study if
they have pain as a result of oral mucositis and their treating physician
has discussed the need for a gastric tube placement because of their
oral mucositis. Oral mucositis is the medical term used to describe
the inflammation and painful sores that develop in the mouth.
The study will last for 12 weeks with 9 clinic visits required.
Postherpetic Neuralgia (pain after shingles)
IRB #019-06 [S,S]-Reboxetine Dose-range
Finding Trial: A 16-week, Randomized, Double-blind, Placebo and Pregabalin
Controlled, Multi-center Trial of [S,S]-Reboxetine in Patients with
Postherpetic Neuralgia (PHN) - Protocol A6061026
Principal Investigator: Russell K. Portenoy,
MD
Contact: Andrew Kobets 212-844-1491
Status: Open for Enrollment
Design: Pfizer, Inc. is conducting a research
study with a drug called [S,S]-Reboxetine ([S,S]-RBX) as a therapy in
the management of chronic pain following a shingles infection, called
postherpetic neuralgia (PHN). The study drug is a new investigational
preparation. An investigational product is one that has not yet been
approved by the U.S. Food and Drug Administration (FDA).
The purpose of this research study is to evaluate the effectiveness,
safety, and tolerability of [S,S]-RBX in subjects with postherpetic
neuralgia (PHN).
Because this is a research study, [S,S]-RBX will only be given during
study participation, and if the subject continues in the open label
extension study (Protocol Number: A6061029) that follows this study.
The open-label study allows participants to continue to use [S,S]-RBX
for an extended period of time. To enter the open label extension study
certain conditions must be met including the completion of this current
study.
In this study, participants will either get [S,S]-RBX, or Pregabalin,
or placebo. Placebo is a pill that does not contain any drug. Pregabalin
(marketed as Lyrica®) is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of PHN. The order in which the study drug ([S,S]-RBX,
or Pregabalin, or placebo) is given will be randomized. In this study,
randomization means that you have a 75% chance of getting [S,S] RBX,
and a 12.5% chance of getting either Pregabalin or placebo. This means
2 out of 8 people will get placebo or pregabalin. The study medication
will be assigned in a mixed-up order so that neither you nor the study
doctor will know if you get placebo or Pregabalin or [S,S]-RBX (this
is referred to as ‘double-blind’).
During the course of the study subjects will be required to come to
the clinic 9 times. Some study visits may be very short (for example,
half an hour) whereas others may be longer (for example, 2 hours). The
study should last about 16 weeks in total.
Eligible subjects will be compensated for their time and travel expense
required to participate in the study.
Postherpetic Neuralgia (pain after shingles)
IRB #130-06 An Open-Label Extension Trial
Assessing the Safety and Tolerability of [S,S]-Reboxetine in Patients
with Postherpetic Neuralgia (PHN) - Protocol A6061029
Principal Investigator: Russell K. Portenoy,
MD
Contact: Andrew Kobets 212-844-1491
Status: Open for Enrollment
Design: This is an open-label extension
study of [S,S]-RBX for subjects with chronic pain following a shingles
infection, called postherpetic neuralgia (PHN). Eligibility includes
only those participants who have completed the preceding 16 week double-blind
protocol A6061026 (IRB #019-06).
Open label means that all subjects will
receive the active study drug [S,S]-RBX and that both the subject and
the study physician will know the dose that is being prescribed. The
aims of this study are to assess the long-term safety, efficacy, and
tolerability of [S,S]-RBX.
There are different doses of [S,S]-RBX included in this study as the
dose is adjusted (titrated) based on the subject’s response to
the study medication. During the first week, subjects will start with
a total daily dose of 1 mg [S,S]-RBX. Dose increases may occur at any
time after Day 7 (Visit 2) and will be conducted in 1 mg increments
up to a maximum total daily dose of 8 mg of [S,S]-RBX. Stepwise dose
reduction is also conducted in 1 mg decrements.
The study investigators will be attempting to adjust the dose until
favorable clinical effects develop. The purpose of increasing or decreasing
the dose is to find out what the best dose for each participant might
be. Dose adjustment may occur either at scheduled clinic visits, or
at an unscheduled visit.
If subjects are eligible and agree to participate, their participation
in this study may last up to 2 years. Subjects will be asked to return
to the study clinic on 14 occasions during the course of the study.
Eligible subjects will be compensated for their time and travel expense
required to participate in the study.
Postherpetic Neuralgia (pain after shingles)
IRB #186-05 A Multicenter, Randomized,
Double-Blind, Placebo-Controlled, 2-Period Crossover Study Conducted
Under In-House Blinding Conditions to Evaluate the Safety and Efficacy
of Oral MK-0686 in the Treatment of Postherpetic Neuralgia
Principal Investigator: Russell K. Portenoy,
MD
Contact: Andrew Kobets 212-844-1491
Status: Open for Enrollment
Design: If the pain from shingles does
not go away, it is called postherpetic neuralgia (PHN). Only a small
number of people with shingles develop PHN.
Merck & Co., Inc. is conducting a research study of an experimental
drug called MK-0686 as a therapy in the management of PHN. The study
drug, MK-0686, is a new investigational preparation. An investigational
product is one that has not yet been approved by the U.S. Food and Drug
Administration (FDA).
Participants must be between the ages of 18 and 80 to participate in
this study and have a diagnosis of PHN with pain persisting for at least
6 months.
Subjects will be assigned by chance to get either MK-0686 or placebo
(a look-alike with no active ingredients, sometimes called a sugar pill)
during each treatment period of the study. Neither the subjects nor
the study doctor will know which of these they are receiving. Every
participant will receive MK-0686 for a period of time during the study.
There will also be a period of time when all participants will receive
placebo and not active treatment.
The study is expected to last for 7 weeks with up to 8 clinic visits
expected.
Eligible subjects will be compensated for their time and travel expense
required to participate in the study.
Spinal Cord Injury
IRB #197-04 Study of Levetiracetam in Patients
with Central Pain Following Spinal Cord Injury: A Randomized Crossover
Study
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Jeanne Lapin, RN, 212-844-1475
Status: Open for Enrollment
Design: Levetiracetam (Keppra®) is a drug
approved by the U.S. Food and Drug Administration (FDA) for the treatment
of epilepsy. Research data suggest that it may be useful in the treatment
of neuropathic pain (pain caused by nerve damage). The purpose of this research
study is to evaluate the safety and efficacy (ability to decrease pain) of
levetiracetam for the treatment of central neuropathic pain following complete
spinal cord injury. Levetiracetam is not currently approved by the FDA for
the treatment of pain and is, therefore, considered experimental.
This study will be conducted at the Bronx Veterans Administration Medical
Center with oversight from Beth Israel Medical Center. The study is expected
to last up to 16 weeks with all of the study visits taking place at the Bronx
Veterans Administration Medical Center.
This is a two-phase study designed to assess the efficacy and safety of levetiracetam
to treat neuropathic pain. The first phase is an open-label trial of levetiracetam
with escalating doses. Subjects who respond to levetiracetam (decreased daily
'pain on average') will be enrolled in the second phase. In this second phase,
subjects will receive either the study drug (levetiracetam) or a placebo tablet
(a tablet that does not contain any active drug). Each period includes a baseline
period, a period of drug titration and a maintenance period.
Testosterone Replacement in Opioid-Treated Hypogonadal
Men with Persistent Pain
IRB #229-04 Safety and Analgesic Efficacy
of Testosterone Replacement in Hypogonadal Opioid-Treated Chronic Pain
Patients: A Controlled Trial
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Helena Knotkova, PhD, 212-420-3823
Status: Open for Enrollment
Design: The study drug, AndroGel® is a clear
colorless gel containing 1% testosterone. AndroGel® has been approved
by the Food and Drug Administration (FDA) and is currently available in the
United States. It is being studied to determine if testosterone replacement
can improve pain control in male subjects on an opioid (narcotic) analgesic
and who have been found to have hypogonadism (a low level of testosterone
in the body).
AndroGel® provides continuous transdermal (through the skin) delivery
of testosterone for 24 hours following a single application to skin’s
surface of the shoulders, upper arms and/or abdomen. In this study, patients
will receive either the study drug (AndroGel®) or a placebo gel. The placebo
gel will contain an inactive substance (no active drug).
Adult male patients between the ages of 18 and 50 who are receiving an opioid
for the treatment of chronic pain will be considered for this 6-week study.
Eligibility includes a total testosterone level below 300 ng/dl and a free
testosterone of below 50 pg/ml.
The study requires 4 visits to assess safety, effectiveness and tolerability.
For more information on these studies, or to see if your patients qualify
for participation, please write or call:
Jeanne A. Lapin, RN
Department of Pain Medicine and Palliative Care
Institute for Education and Research
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Telephone: (212) 844-1475
Email: stoppain@chpnet.org
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