MedTrace Logo

Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

NCT00864097 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2021-02-26

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

Conditions

Interventions

BIOLOGICAL

tanezumab

IV tanezumab 10 mg every 8 weeks (through Week 16)

DRUG

diclofenac

Oral diclofenac SR 75 mg BID for 32 weeks

BIOLOGICAL

tanezumab

IV tanezumab 5 mg every 8 weeks (through Week 16)

DRUG

diclofenac

Oral diclofenac SR 75 mg BID for 32 weeks

BIOLOGICAL

tanezumab

IV tanezumab 2.5 mg every 8 weeks (through Week 16)

DRUG

diclofenac

Oral diclofenac SR 75 mg BID for 32 weeks

DRUG

diclofenac

Oral diclofenac SR 75 mg BID for 32 weeks

OTHER

IV placebo

IV placebo to match tanezumab every 8 weeks (through Week 16)

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-11
Primary Completion
2010-11-16
Completion
2010-11-24

Countries

  • Austria
  • France
  • Germany
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

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 NCT00864097 on ClinicalTrials.gov