CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,021 enrolled
Drug / intervention
NSAID +2 moredrug
Likely dose
Tanezumab 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02528188
NCT02528188Phase 3Completed
CompareCT.gov

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Pfizer·interventional·Posted Aug 19, 2015·Updated Jan 10, 2020

In Brief

A Phase 3 clinical trial evaluating NSAID, Tanezumab 2.5 mg, and 1 other intervention for Chronic Pain and 2 related conditions. Completed, enrolled 3,021 participants across 507 sites in 18 countries.

Detailed Summary

The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
CountriesAustralia, Brazil, Bulgaria, Colombia, Croatia, Japan, Lithuania, Mexico, New Zealand, Peru, Philippines, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 19, 2015
Enrollment StartJul 21, 2015
Primary CompletionOct 5, 2018
Study CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.9 years ago

Interventions

NSAIDdrug

Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks

Tanezumab 2.5 mgbiological

Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks

Tanezumab 5 mgbiological

Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks