drugset / Trial / NCT00710424

A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

NCT00710424 ↗

Phase 3 Completed 297 enrolled Jazz Pharmaceuticals
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

Timeline

Start
2005-07
Primary completion
2006-06
Completion
2006-06

Outcome

Missed primary endpoint

registry analysis (unspecified test); Sativex vs Placebo; p = 0.634; estimated treatment effect -0.12 (95% CI -0.60 to 0.36); ANCOVA NCT00710424 ↗

registry analysis (unspecified test); Sativex vs Placebo; p = 0.521; Odds Ratio (OR) 0.857 (95% CI 0.537 to 1.370); Regression, Logistic NCT00710424 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nabiximols Other / unclassified — —

Indications