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Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

NCT02528188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3021

Last updated 2020-01-10

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-21
Primary Completion
2018-10-05
Completion
2019-02-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Colombia
  • Croatia
  • Japan
  • Lithuania
  • Mexico
  • New Zealand
  • Peru
  • Philippines
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Taiwan
  • 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 NCT02528188 on ClinicalTrials.gov