Status:
COMPLETED
Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)
Lead Sponsor:
Centrexion Therapeutics
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00667654
Start Date
August 1 2007
End Date
August 1 2016
Last Update
December 6 2016
Active Locations (1)
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1
Clinical Phamacology Study Group
Worcester, Massachusetts, United States, 01610