A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CNTX-4975-05
Qutenza
Lidocaine (without epinephrine)
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee
Eligibility 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.
Sites / Locations
- Well Pharma Medical Research, Corp
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CNTX-4975-05 Intra-Articular (IA) Injection
Topical 8% Capsaicin Patch
Arm Description
Receives IA injection into the most painful OA knee.
Receives Capsaicin Patch on posterior rib cage.
Outcomes
Primary Outcome Measures
Capsaicin Pharmacokinetics - AUC0-t
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.
Capsaicin Pharmacokinetics - AUC0-inf
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.
Capsaicin Pharmacokinetics - Cmax
Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.
Secondary Outcome Measures
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
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Number of participants with TEAEs, which includes laboratory test variables
IA knee Lidocaine Systemic Pharmacokinetics - Concentration
System exposure to lidocaine measured by plasma concentration
Full Information
NCT ID
NCT03576508
First Posted
June 11, 2018
Last Updated
November 13, 2018
Sponsor
Centrexion Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT03576508
Brief Title
A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
September 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centrexion Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNTX-4975-05 Intra-Articular (IA) Injection
Arm Type
Experimental
Arm Description
Receives IA injection into the most painful OA knee.
Arm Title
Topical 8% Capsaicin Patch
Arm Type
Active Comparator
Arm Description
Receives Capsaicin Patch on posterior rib cage.
Intervention Type
Drug
Intervention Name(s)
CNTX-4975-05
Other Intervention Name(s)
trans-capsaicin
Intervention Description
1 mg (2mL) IA injection
Intervention Type
Drug
Intervention Name(s)
Qutenza
Other Intervention Name(s)
cis-capsaicin
Intervention Description
8% topical patch
Intervention Type
Drug
Intervention Name(s)
Lidocaine (without epinephrine)
Intervention Description
15 mL IA injection of 2% lidocaine (without epinephrine)
Primary Outcome Measure Information:
Title
Capsaicin Pharmacokinetics - AUC0-t
Description
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.
Time Frame
Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Title
Capsaicin Pharmacokinetics - AUC0-inf
Description
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.
Time Frame
Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Title
Capsaicin Pharmacokinetics - Cmax
Description
Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.
Time Frame
Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment
Description
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
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)
Title
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Description
Number of participants with TEAEs, which includes laboratory test variables
Time Frame
Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)
Title
IA knee Lidocaine Systemic Pharmacokinetics - Concentration
Description
System exposure to lidocaine measured by plasma 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]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Stevens, MD
Organizational Affiliation
Centrexion Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Well Pharma Medical Research, Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
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