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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03576508

Enrollment

Registered

2018-07-03

Start date

2018-06-25

Completion date

2018-09-06

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis, Knee

Brief summary

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

Interventions

DRUGCNTX-4975-05

1 mg (2mL) IA injection

DRUGQutenza

8% topical patch

DRUGLidocaine (without epinephrine)

15 mL IA injection of 2% lidocaine (without epinephrine)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026