Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)

Completed · Phase 2

Conditions studied: Osteoarthritis of the Knee

In brief

This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

Key facts

Study ID

NCT00667654

Run by

Centrexion Therapeutics

People needed

54

Starts

2007-08-01

Expected to finish

2016-08-01

Last updated by the study team

2016-12-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients aged 40 years or over.
• Body mass index (BMI) of 35 or less.
• History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
• X-Ray of the target knee.
• Willing and able to complete the study procedures.

You may not qualify if…

• Female patients who are pregnant or lactating or who plan to get pregnant.
• Clinically significant form of joint disease other than OA.
• Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
• Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
• Arthroscopic surgery on the target knee within 6 months.

Where it is running

• Clinical Phamacology Study Group — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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