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

Sponsor
SK Life Science, Inc.
Study ID
NCT00492323
Phase
PHASE2
Status
Completed

Conditions

  • Herpes Zoster
  • Neuralgia
  • Postherpetic Neuralgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • placebo — DRUG
    twice daily for 4 weeks
  • carisbamate — DRUG
    200 mg tablet twice daily for 4 weeks

Study Details

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.

Key Dates

Start date
Mar 31, 2007
Status verified
Apr 2018
Primary completion
Jun 30, 2008
Completion
Jun 30, 2008

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 002
    placebo twice daily for 4 weeks
  • Experimental: 001
    carisbamate 200 mg tablet twice daily for 4 weeks

Primary Outcome Measure

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 ]

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