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

NCT03576508 | Completed Phase 1 FDA Drug

• 1 other identifier: CNTX-4975i-OA-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• 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)

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

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

• 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]

Study Arms (2)

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

EXPERIMENTAL

Receives IA injection into the most painful OA knee.

Drug: CNTX-4975-05; Drug: Lidocaine (without epinephrine)

Topical 8% Capsaicin Patch

ACTIVE COMPARATOR

Receives Capsaicin Patch on posterior rib cage.

Drug: Qutenza

Interventions

CNTX-4975-05 DRUG

1 mg (2mL) IA injection

Also known as: trans-capsaicin

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

Qutenza DRUG

8% topical patch

Also known as: cis-capsaicin

Topical 8% Capsaicin Patch

Lidocaine (without epinephrine) DRUG

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

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

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (1)

Well Pharma Medical Research, Corp

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Capsaicin; zucapsaicin; Lidocaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Randall Stevens, MD

  Centrexion Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 3, 2018
• Study Start: June 25, 2018
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

US (1)