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Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

NCT02709486 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 849

Last updated 2019-06-26

Study results available
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Summary

Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions.

The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

Conditions

  • Osteoarthritis, Hip
  • Osteoarthritis, Knee

Interventions

DRUG

Tanezumab

2.5 mg

DRUG

Tanezumab

5 mg

DRUG

Placebo

Placebo

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
2016-03-02
Primary Completion
2018-06-08
Completion
2018-11-14
FDA Drug
Yes

Countries

  • Austria
  • Bulgaria
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02709486 on ClinicalTrials.gov