NCT00809354

Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,720 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Detailed description

This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Conditions

• Osteoarthritis
• Arthritis

Interventions

Type	Name	Description
DRUG	NSAID	IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
BIOLOGICAL	tanezumab	IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
BIOLOGICAL	tanezumab	IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
BIOLOGICAL	tanezumab	IV tanezumab 5 mg every 8 weeks (through Week 48)
DRUG	NSAID	Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
BIOLOGICAL	tanezumab	IV tanezumab 10 mg every 8 weeks (through Week 48)
DRUG	NSAID	Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Timeline

• Start date: 2009-02-12
• Primary completion: 2010-10-28
• Completion: 2011-01-12
• First posted: 2008-12-17
• Last updated: 2021-06-24
• Results posted: 2021-06-24

Locations

333 sites across 12 countries: United States, Canada, Colombia, India, Mexico, Netherlands, Philippines, Russia, South Africa, South Korea, Spain, Ukraine