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An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492323
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : May 1, 2018
Information provided by (Responsible Party):
SK Life Science, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia.

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Neuralgia Herpes Zoster Drug: placebo Drug: carisbamate Phase 2

Detailed Description:
Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia.
Study Start Date : March 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Arm Intervention/treatment
Placebo Comparator: 002
placebo twice daily for 4 weeks
Drug: placebo
twice daily for 4 weeks

Experimental: 001
carisbamate 200 mg tablet twice daily for 4 weeks
Drug: carisbamate
200 mg tablet twice daily for 4 weeks

Primary Outcome Measures :
  1. The mean of the last 7 average daily PHN scores of the first treatment period on days when study drug is taken. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. The means of the last 7 average daily PHN pain scores with no use of rescue medication, the last 7 current daily PHN pain scores, the last 7 maximum daily PHN pain scores and the last 7 daily sleep interference scores. [ Time Frame: 4 weeks (2 four-week treatment periods (cross-over design ) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of postherpetic neuralgia (PHN) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash
  • Experienced postherpetic neuralgia pain on a daily basis for the past 3 months
  • Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening.

Exclusion Criteria:

  • History of a poor response to 3 or more medications for postherpetic neuralgia (PHN), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: Antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch
  • currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued
  • past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for PHN pain
  • currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period
  • Prior exposure to RWJ-333369 (carisbamate).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00492323

Sponsors and Collaborators
SK Life Science, Inc.
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Responsible Party: SK Life Science, Inc. Identifier: NCT00492323    
Other Study ID Numbers: CR010363
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by SK Life Science, Inc.:
pain following the healing of rashes and blisters
herpes virus
varicella-zoster virus
Additional relevant MeSH terms:
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Herpes Zoster
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases