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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576508
• Other study ID #: CNTX-4975i-OA-102
• Status: Completed
• Phase: Phase 1
• Start date: June 25, 2018
• Est. completion date: September 6, 2018

Study information

• Verified date: November 2018
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• CNTX-4975-05
1 mg (2mL) IA injection
• Qutenza
8% topical patch
• Lidocaine (without epinephrine)
15 mL IA injection of 2% lidocaine (without epinephrine)

Locations

Country	Name	City	State
United States	Well Pharma Medical Research, Corp	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsaicin Pharmacokinetics - AUC0-t	Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.	Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Primary	Capsaicin Pharmacokinetics - AUC0-inf	Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.	Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Primary	Capsaicin Pharmacokinetics - Cmax	Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.	Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment	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	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)
Secondary	Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)	Number of participants with TEAEs, which includes laboratory test variables	Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)
Secondary	IA knee Lidocaine Systemic Pharmacokinetics - Concentration	System exposure to lidocaine measured by plasma 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]