drugset / Trial / NCT02301234

Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

NCT02301234

Phase 3 Completed 111 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

Timeline

Start
2015-03-25
Primary completion
2016-09-19
Completion
2016-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulranumab Monoclonal antibody 1 mg Subcutaneous
Subject Fulranumab Monoclonal antibody 3 mg Subcutaneous
Comparator Celecoxib Other / unclassified 100 mg Oral

Indications