Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)
- Registration Number
- NCT00667654
- Lead Sponsor
- Centrexion Therapeutics
- 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 4975 in terms of onset, extent and duration of pain relief.
- 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 knee will be assessed before, during and after administration of the study drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100-200 µg CNTX-4975 CNTX-4975 single dose 600-700 µg CNTX-4975 CNTX-4975 Total dose delivered as two separate lower doses 800 µg CNTX-4975 CNTX-4975 Total dose delivered as two separate lower doses 300-425 µg CNTX-4975 CNTX-4975 Total dose delivered as two separate lower doses 900-1000 µg CNTX-4975 CNTX-4975 Total dose delivered as two separate lower doses
- Primary Outcome Measures
Name Time Method To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times 12 Weeks
- Secondary Outcome Measures
Name Time Method Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975 12 Weeks Change from baseline to Week 12 in WOMAC subscale score Baseline to 12 weeks
Trial Locations
- Locations (1)
Clinical Phamacology Study Group
🇺🇸Worcester, Massachusetts, United States