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

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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.


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
7000 SW 62 Ave.
Miami, Florida 33143
305-284-8483
?
mi
from
Miami, FL
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