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Completed

NCT Number: NCT03576508

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

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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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Well Pharma Medical Research, Corp

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CNTX-4975-05

Drug

1 mg (2mL) IA injection

Other names: trans-capsaicin

Qutenza

Drug

8% topical patch

Other names: cis-capsaicin

Lidocaine (without epinephrine)

Drug

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

Primary outcomes

  1. Capsaicin Pharmacokinetics - AUC0-t

    Time frame: 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.

  2. Capsaicin Pharmacokinetics - AUC0-inf

    Time frame: 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.

  3. Capsaicin Pharmacokinetics - Cmax

    Time frame: 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 outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment

    Time frame: 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

  2. Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)

    Time frame: Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)

    Number of participants with TEAEs, which includes laboratory test variables

  3. IA knee Lidocaine Systemic Pharmacokinetics - Concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centrexion Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 3, 2018
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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