Trials / Completed
CompletedNCT02528188
Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,021 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NSAID | Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks |
| BIOLOGICAL | Tanezumab 2.5 mg | Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks |
| BIOLOGICAL | Tanezumab 5 mg | Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks |
Timeline
- Start date
- 2015-07-21
- Primary completion
- 2018-10-05
- Completion
- 2019-02-27
- First posted
- 2015-08-19
- Last updated
- 2020-01-10
- Results posted
- 2020-01-10
Locations
507 sites across 18 countries: United States, Australia, Brazil, Bulgaria, Colombia, Croatia, Japan, Lithuania, Mexico, New Zealand, Peru, Philippines, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02528188. Inclusion in this directory is not an endorsement.