A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 11/16/2018 |
| Start Date: | June 25, 2018 |
| End Date: | September 6, 2018 |
A Two-Period Crossover Study to Compare the Systemic Exposure to Trans-Capsaicin and Cis-Capsaicin From an Intra-Articular Injection of CNTX-4975-05 (Trans-capsaicin for Injection) and Topical 8% Capsaicin Patch (Qutenza®) in Subjects With Painful Knee Osteoarthritis
This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and
female participants with painful knee osteoarthritis.
female participants with painful knee osteoarthritis.
Key Inclusion Criteria:
- Body mass index (BMI) between 18.0-35.0 kg/m^2
- Subject has moderate to severe painful osteoarthritis in one knee while walking (index
knee); contralateral knee may or may not have osteoarthritis, pain should be none to
mild in the non-index knee
- Confirmation of the OA of the index knee: American College of Rheumatology (ACR)
diagnostic criteria
- Subject has intact skin at the location of the dosing sites (patch or injection)
Key Exclusion Criteria:
- Subject has any other form of arthritis, such as, but not limited to, rheumatoid
arthritis, psoriatic arthritis, gout, systemic lupus erythematosus, etc.
- Subject has a dermatological condition that may contraindicate participation,
including any compromise in skin integrity at the CNTX-4975-05 injection site or the
Qutenza® skin application site, e.g., severe or cystic acne, psoriasis, eczema, atopic
dermatitis, active or treated cancer, etc.
We found this trial at
1
site
Click here to add this to my saved trials
