Back to resultsA Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
Primary Purpose
Osteoarthritis, Knee, Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CGS-200-1
CGS-200-5
CGS-200 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis (OA) of both knees;
- OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within the past 6 months;
- Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) <40 mm/hr;
- Chronic knee pain in at least 1 knee for > 3 months;
- WOMAC pain score of > 250 (using VAS WOMAC format) at screening, and at baseline, in at least one knee;
- Knee pain score of > 5 on the NRS pain scale at screening, and at baseline, in at least one knee;
- Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic knee injury in medical history);
- No burning-stinging pain, unrelated to subject's knee pain, at intended site of application;
- Knee pain must be greater than pain in any other part of subject's body;
- American College of Rheumatology (ACR) global functional status I, II, or III (excluding IV).
Exclusion Criteria:
- Spontaneously improving or rapidly deteriorating OA of the knee;
- Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout), Paget's disease of bone, or any other disease affecting the joints that are inconsistent with a diagnosis of idiopathic OA;
- Labile or poorly controlled hypertension;
- Use of steroids for 1 month prior to screening, or intraarticular-visco-supplementation within 3 months prior to screening;
- Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks prior to screening;
- Used topically applied products (including emollients or moisturizers) on or in the vicinity of the knees or shaved the knees within 2 days prior to the first application of study drug; or an open wound near the knee; cutaneous erythema or edema; any inflammatory skin lesions such as eczema or psoriasis; cutaneous infections; or any other compromise of the skin;
- Requires or anticipates any surgical procedure within 3 months prior to screening, has had surgery on the affected joint within 6 months prior to screening, has a prosthesis in either knee, or would require surgery while participating in the trial.
Sites / Locations
- Clinical Research of West Florida
- Clinical Research of West Florida, Inc.
- McIlwain Medical Group
- CTI Clinical Research Center
- Radiant Research, Inc.
- Radiant Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
CGS-200-1
CGS-200-5
CGS-200 Vehicle
Arm Description
CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.
CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.
CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35
The Primary Efficacy endpoint of this study will be to examine the extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of Vehicle (CGS-200-0), CGS-200-1 and CGS-200-5 at Baseline (< 30 minutes prior to first daily application) and Day 35 (31 days after fourth daily application).
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Reduction in pain is expressed as a difference from baseline to Study Day 35. Positive numbers indicate increases and negative numbers indicate decreases. .
Secondary Outcome Measures
Secondary Efficacy Endpoint #1: Extent of Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 5, 19, 64 and 94.
The extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of CGS-200-0, CGS-200-1 and CGS-200-5 from Baseline to Day 5, 19, 64 and Day 94.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Positive numbers indicate increases and negative numbers indicate decreases.
Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug.
The average amount of burning-sting pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.
Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 2 questions relating to stiffness that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 200. Positive numbers indicate increases and negative numbers indicate decreases.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.
Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function score is 17 questions relating to physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 1700. Positive numbers indicate increases and negative numbers indicate decreases.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03528369
Brief Title
A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
Official Title
A Phase 2 Double-Blind Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% Capsaicin Topical Liquid), CGS-200-5 (5% Capsaicin Topical Liquid), and CGS-200-0 (Vehicle, No Capsaicin)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
October 14, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Propella Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi-center, randomized, double-blind clinical trial to examine the comparative effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content) (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied at the clinic for 60 minutes on each of four consecutive days.
Detailed Description
Subjects will be randomized to one of the three Arms in this study: CGS-200-1 or CGS-200-5 or CGS-200 Vehicle (CGS-200-0). All subjects will receive 4 consecutive days of treatment and will then be followed up until the Day 94 visit.
Even though both knee(s) will receive application of study test materials, with regard to reduction in WOMAC pain and VAS pain score associated with study treatments, only one knee will be indicated as the "Study Knee". This will be the knee with the highest WOMAC pain score at screening. If both knees have equal WOMAC pain scores at baseline, then the right knee will be considered the "Study Knee" with regard to WOMAC pain and VAS pain score reduction.
Data will be collected from Day 1 through Day 5 and then again on Days 19, 35, 64 and 94 for efficacy, tolerability, and safety measures. The Investigators, all site staff and Clinical Research Organization (CRO) personnel (except the Medical Monitor providing safety oversight) directly involved in the study will remain blinded to the treatment assignment throughout the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGS-200-1
Arm Type
Experimental
Arm Description
CGS-200-1 (1% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.
Arm Title
CGS-200-5
Arm Type
Experimental
Arm Description
CGS-200-5 (5% Capsaicin content), a topical analgesic liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.
Arm Title
CGS-200 Vehicle
Arm Type
Sham Comparator
Arm Description
CGS-200 Vehicle (no Capsaicin), a topical liquid. A single dose will be topically applied to both knees for 60 minutes on Visit 2 on Day 1, Day 2, Day 3, and Day 4.
Intervention Type
Drug
Intervention Name(s)
CGS-200-1
Other Intervention Name(s)
CGS-200 (1% capsaicin)
Intervention Description
CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.
Intervention Type
Drug
Intervention Name(s)
CGS-200-5
Other Intervention Name(s)
CGS-200 (5% capsaicin)
Intervention Description
CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.
Intervention Type
Drug
Intervention Name(s)
CGS-200 Vehicle
Other Intervention Name(s)
CGS-200 (0% capsaicin)
Intervention Description
CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35
Description
The Primary Efficacy endpoint of this study will be to examine the extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of Vehicle (CGS-200-0), CGS-200-1 and CGS-200-5 at Baseline (< 30 minutes prior to first daily application) and Day 35 (31 days after fourth daily application).
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Reduction in pain is expressed as a difference from baseline to Study Day 35. Positive numbers indicate increases and negative numbers indicate decreases. .
Time Frame
35 days after the last dose of study drug on Day 4
Secondary Outcome Measure Information:
Title
Secondary Efficacy Endpoint #1: Extent of Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 5, 19, 64 and 94.
Description
The extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of CGS-200-0, CGS-200-1 and CGS-200-5 from Baseline to Day 5, 19, 64 and Day 94.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Positive numbers indicate increases and negative numbers indicate decreases.
Time Frame
Days 5, 19, 65 and 94 after the last dose of study drug on Day 4
Title
Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug.
Description
The average amount of burning-sting pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.
Time Frame
60 minutes after study drug application on Study Days 1,2,3,4
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.
Description
Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 2 questions relating to stiffness that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 200. Positive numbers indicate increases and negative numbers indicate decreases.
Time Frame
Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.
Description
Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function score is 17 questions relating to physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 1700. Positive numbers indicate increases and negative numbers indicate decreases.
Time Frame
Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4
Other Pre-specified Outcome Measures:
Title
Number of Subjects With Skin Reactions of Erythema or Pruritus.
Description
Investigator reports of erythema or pruritus at the site of study drug application.
Time Frame
Study Day 1 through Study Day 35 after the first application of study drug (Study Day 1)
Title
Number of Subjects With Durability of Efficacy Response
Description
Subjects who had a clinical response (i.e., reduction of at least 50% in WOMAC pain score) at the Day 5 visit and who remained at this reduction of pain score or lower at Days 19, 35, 64, and the Day 94 visit were considered to have a durable clinical response through Day 94. Subjects who had a clinical response at no more than one of the post Day 5 visits were considered to have a durable response through the last day at which reduction in WOMAC pain score is at least 50%. Subjects who had less than 50% WOMAC pain score reduction on two or more of the post Day 5 visits were considered to have failed to achieve a durable clinical response.
Time Frame
Days 35, 64 and 94 day after the last dose of study drug on Study Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis (OA) of both knees;
OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within the past 6 months;
Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) <40 mm/hr;
Chronic knee pain in at least 1 knee for > 3 months;
WOMAC pain score of > 250 (using VAS WOMAC format) at screening, and at baseline, in at least one knee;
Knee pain score of > 5 on the NRS pain scale at screening, and at baseline, in at least one knee;
Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic knee injury in medical history);
No burning-stinging pain, unrelated to subject's knee pain, at intended site of application;
Knee pain must be greater than pain in any other part of subject's body;
American College of Rheumatology (ACR) global functional status I, II, or III (excluding IV).
Exclusion Criteria:
Spontaneously improving or rapidly deteriorating OA of the knee;
Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout), Paget's disease of bone, or any other disease affecting the joints that are inconsistent with a diagnosis of idiopathic OA;
Labile or poorly controlled hypertension;
Use of steroids for 1 month prior to screening, or intraarticular-visco-supplementation within 3 months prior to screening;
Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks prior to screening;
Used topically applied products (including emollients or moisturizers) on or in the vicinity of the knees or shaved the knees within 2 days prior to the first application of study drug; or an open wound near the knee; cutaneous erythema or edema; any inflammatory skin lesions such as eczema or psoriasis; cutaneous infections; or any other compromise of the skin;
Requires or anticipates any surgical procedure within 3 months prior to screening, has had surgery on the affected joint within 6 months prior to screening, has a prosthesis in either knee, or would require surgery while participating in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vice President Clinical Operations
Organizational Affiliation
Vizuri Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
McIlwain Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Radiant Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
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