drugset / Trial / NCT01091116

A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

NCT01091116 ↗

Phase 2 Completed 423 enrolled Menarini Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Timeline

Start
2010-03
Primary completion
2011-02
Completion
2011-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Low Dose vs Mid Dose vs High Dose vs Single High Dose vs Placebo; p = 0.5263; ANCOVA NCT01091116 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasitibant Small molecule 0.125 mg Other
Subject Fasitibant Small molecule 0.25 mg Other
Subject Fasitibant Small molecule 0.5 mg Other

Indications