Clinical trial NCT03576508: A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Knee
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-07-03
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Capsaicin Pharmacokinetics - AUC0-t
timeFrame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
measure: Capsaicin Pharmacokinetics - AUC0-inf
timeFrame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
measure: Capsaicin Pharmacokinetics - Cmax
timeFrame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment
timeFrame: 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)
measure: Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
timeFrame: Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)
measure: IA knee Lidocaine Systemic Pharmacokinetics - Concentration
timeFrame: 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]
Other outcomes:
Locations:
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp
state: Florida
Study officials:
affiliation: Centrexion Therapeutics
name: Randall Stevens, MD
role: STUDY_CHAIR
References: