drugset / Trial / NCT00794430

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

NCT00794430 ↗

Phase 2 Completed 161 enrolled Vernalis (R&D) Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-12
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Indantadol Unknown 100 mg Oral
Subject Indantadol Unknown 200 mg Oral
Subject Indantadol Unknown 300 mg Oral
Subject Indantadol Unknown 400 mg Oral