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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2018-09-06

Brief Summary

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

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Receives IA injection into the most painful OA knee.

Group Type EXPERIMENTAL

CNTX-4975-05

Intervention Type DRUG

1 mg (2mL) IA injection

Lidocaine (without epinephrine)

Intervention Type DRUG

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

Topical 8% Capsaicin Patch

Receives Capsaicin Patch on posterior rib cage.

Group Type ACTIVE_COMPARATOR

Qutenza

Intervention Type DRUG

8% topical patch

Interventions

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CNTX-4975-05

1 mg (2mL) IA injection

Intervention Type DRUG

Qutenza

8% topical patch

Intervention Type DRUG

Lidocaine (without epinephrine)

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

Intervention Type DRUG

Other Intervention Names

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trans-capsaicin cis-capsaicin

Eligibility Criteria

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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)

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No