Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).

Sponsor
SK Life Science, Inc.
Study ID
NCT00501202
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Mononeuropathy
  • Diabetic Neuralgia
  • Diabetic Neuropathy, Painful
  • Diabetic Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of Diabetic Peripheral Neuropathy (DPN).

Key Dates

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

Study Design

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

Arms

  • Placebo Comparator: 002
    placebo twice daily for 4 weeks
  • Experimental: 001
    RWJ-333369 (carisbamate) 200 mg tablet twice daily for 4 weeks

Primary Outcome Measure

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

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