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A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

NCT00597649 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2009-06-30

No results posted yet for this study

Summary

This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Conditions

  • Chronic Peripheral Neuropathy Pain in Diabetics

Interventions

DRUG

Bicifadine

SR dosage form of 400 mg bid or tid for one year

Sponsors & Collaborators

  • XTL Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mark Roffman, PhD · XTL Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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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 NCT00597649 on ClinicalTrials.gov