A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis

Centrexion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: Qutenza; Drug: CNTX-4975-05; Drug: Lidocaine (without epinephrine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03576508

CNTX-4975i-OA-102

Details and patient eligibility

About

This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.

Enrollment: 16 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

CNTX-4975-05 Intra-Articular (IA) Injection

Experimental group

Description:

Receives IA injection into the most painful OA knee.

Treatment:

Drug: Lidocaine (without epinephrine)

Drug: CNTX-4975-05

Topical 8% Capsaicin Patch

Active Comparator group

Description:

Receives Capsaicin Patch on posterior rib cage.

Treatment:

Drug: Qutenza