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

NCT00501202 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2018-05-01

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DRUG

placebo

twice daily for 4 weeks

DRUG

RWJ-333369 (carisbamate)

200 mg tablet twice daily for 4 weeks

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-05-31
Completion
2008-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00501202 on ClinicalTrials.gov