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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centrexion Therapeutics

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.