At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN JAPANESE ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
In Brief
A Phase 3 clinical trial evaluating Celecoxib, Tanezumab 5 mg, and 3 other interventions for Low Back Pain. Completed, enrolled 277 participants across 55 sites.
Detailed Summary
This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).
Study Details
Timeline
Interventions
Orally administered Celecoxib 100 mg twice daily for 56 weeks
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Subcutaneous injection of tanezumab 10 mg every 8 weeks for 56 weeks
Orally administered the placebo twice daily for 56 weeks
Subcutaneous injection of the placebo every 8 weeks for 56 weeks