drugset / Trial / NCT00794430
Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indantadol | Unknown | 100 mg | Oral |
| Subject | Indantadol | Unknown | 200 mg | Oral |
| Subject | Indantadol | Unknown | 300 mg | Oral |
| Subject | Indantadol | Unknown | 400 mg | Oral |