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An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics

NCT00870454 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2013-01-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

Pregabalin 300 mg/d

75 mg/d twice daily for Week 1, followed by 150 mg twice daily for the remainder

DRUG

Carisbamate 800 mg/d

200 mg/d twice daily, titrated up to 400 mg twice daily, as tolerated, by Week 3

DRUG

Carisbamate 1,200 mg/d

200 mg/d twice daily, titrated up to 600 mg twice daily, as tolerated, by Week 3

DRUG

Placebo

Placebo capsules twice daily

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
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Drugs

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 NCT00870454 on ClinicalTrials.gov