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Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

NCT00838799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2011-07-14

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.

Conditions

  • Diabetic Peripheral Neuropathic Pain

Interventions

DRUG

RGH-896

45 mg TID, capsules, 14 weeks.

DRUG

RGH-896

30 mg TID, capsules, 14 weeks.

DRUG

RGH-896

15 mg TID, capsules, 14 weeks.

DRUG

pregabalin

100 mg, TID, capsules, 14 weeks.

DRUG

placebo

TID, capsules, 14 weeks.

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Allyson Gage, PhD · Forest Research Institute, a subsidiary of Forest Laboratories Inc.

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
2009-02-28
Primary Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00838799 on ClinicalTrials.gov