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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

NCT00809354 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2720

Last updated 2021-06-24

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-12
Primary Completion
2010-10-28
Completion
2011-01-12

Countries

  • United States
  • Canada
  • Colombia
  • India
  • Mexico
  • Netherlands
  • Philippines
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809354 on ClinicalTrials.gov