Overview

A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

Status:
Completed

Trial end date:
2007-10-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Antibodies, Monoclonal
Tanezumab

Criteria

Inclusion Criteria:

Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA
(scoring 50 out of 100 on a visual analog scale on knee pain).

Subjects must meet one of the following: unwilling to take non-opiate pain medications, or
for whom non-opiate pain medications have failed, or are candidates for or seeking invasive
interventions such as intraarticular injections, knee arthroplasty, or total knee surgery

Exclusion Criteria:

History or symptoms of autoimmune disorders, cancer within the last 5 years except for
cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to
monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse,
fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral
treatment or insulin, clinically significant neurological disease or clinically significant
psychiatric disorders