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

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: CNTX-4975-05; Drug: Qutenza; Drug: Lidocaine (without epinephrine)

• Registration Number: NCT03576508
• Lead Sponsor: Centrexion Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-22
• Study Start: 2018-06-25
• Study First Posted: 2018-07-03
• Primary Completion: 2018-09-06
• Study Completion: 2018-09-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CNTX-4975-05 Intra-Articular (IA) Injection	Lidocaine (without epinephrine)	Receives IA injection into the most painful OA knee.
CNTX-4975-05 Intra-Articular (IA) Injection	CNTX-4975-05	Receives IA injection into the most painful OA knee.
Topical 8% Capsaicin Patch	Qutenza	Receives Capsaicin Patch on posterior rib cage.

Primary Outcome Measures

Name	Time	Method
Capsaicin Pharmacokinetics - AUC0-t	Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)	Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.
Capsaicin Pharmacokinetics - AUC0-inf	Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)	Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.
Capsaicin Pharmacokinetics - Cmax	Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)	Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment	Day 1 (pre-dose) or Day 8 (pre-dose) [cross over trial Qutenza® 8% patch or CNTX-4975-05 intra-articular (IA) knee injection], and Week 8 (follow-up)	Change from baseline in KOOS of IA injected knees; 5-point Likert scale: 0 (no problems) to 4 (extreme problems); 5 subscales; each assessed separately
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)	Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)	Number of participants with TEAEs, which includes laboratory test variables
IA knee Lidocaine Systemic Pharmacokinetics - Concentration	Day 1 (pre-dose to 3 hours post-dose) or Day 8 (pre-dose to 3 hours post-dose) [Cross over trial Qutenza® 8% patch or CNTX-4975-05 IA knee injection]	System exposure to lidocaine measured by plasma concentration

Trial Locations

Locations (1)

Well Pharma Medical Research, Corp; 🇺🇸 Miami, Florida, United States