Trials / Completed
CompletedNCT00492323
An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- SK Life Science, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo | twice daily for 4 weeks |
| DRUG | carisbamate | 200 mg tablet twice daily for 4 weeks |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2007-06-27
- Last updated
- 2018-05-01
Source: ClinicalTrials.gov record NCT00492323. Inclusion in this directory is not an endorsement.