MedTrace Logo

Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain

NCT00794430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2016-06-03

No results posted yet for this study

Summary

Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13 week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will conclude patient participation in the study.

Conditions

  • Diabetic Peripheral Neuropathic Pain

Interventions

DRUG

V3381

100 mg capsules, titrated to a maximum of 400 mg bid for 13 weeks

DRUG

Placebo

Capsule, bid, for 13 weeks

Sponsors & Collaborators

  • Vernalis (R&D) Ltd

    lead INDUSTRY

Principal Investigators

  • Christine Sang · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Canada
  • Czechia
  • United Kingdom

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 NCT00794430 on ClinicalTrials.gov