Trial Outcomes & Findings for A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control (NCT NCT03528369)

Last Updated: 2024-10-30

Results Overview

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. .

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

35 days after the last dose of study drug on Day 4

Results posted on

2024-10-30

Participant Flow

Subjects were recruited at 6 investigative sites in the US.

Subjects were randomized to receive one of three treatments after the investigator deemed them to qualify for the study.

Participant milestones

Participant milestones
Measure	CGS-200-1 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-200-1: 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.	CGS-200-5 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-200-5: 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.	CGS-200 Vehicle 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Overall Study STARTED	40	42	40
Overall Study COMPLETED	37	41	40
Overall Study NOT COMPLETED	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CGS-200-1 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-200-1: 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.	CGS-200-5 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-200-5: 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.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.	Total n=122 Participants Total of all reporting groups
Age, Continuous	59.4 years n=5 Participants	61.1 years n=7 Participants	59.5 years n=5 Participants	60 years n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	32 Participants n=7 Participants	32 Participants n=5 Participants	102 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	33 Participants n=7 Participants	22 Participants n=5 Participants	83 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	40 participants n=5 Participants	42 participants n=7 Participants	40 participants n=5 Participants	122 participants n=4 Participants
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score	357.0 units on a scale n=5 Participants	350.7 units on a scale n=7 Participants	346.8 units on a scale n=5 Participants	351.5 units on a scale n=4 Participants

PRIMARY outcome

Timeframe: 35 days after the last dose of study drug on Day 4

Population: All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=39 Participants 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-200-1: 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.	CGS-200-5 n=40 Participants 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-200-5: 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.	CGS-200 Vehicle n=39 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35	-130.7 units on a scale Interval -354.0 to 54.0	-159.7 units on a scale Interval -376.0 to 34.0	-99.0 units on a scale Interval -328.0 to 73.0

SECONDARY outcome

Timeframe: Days 5, 19, 65 and 94 after the last dose of study drug on Day 4

Population: All subjects who received at least one dose of study drug. Differences in subjects is due to subjects who withdrew from the study prior to the efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
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. Day 5 WOMAC Pain Score Change from Baseline	-113.1 units on a scale Interval -359.0 to 42.0	-157.5 units on a scale Interval -367.0 to 40.0	-64.5 units on a scale Interval -409.0 to 57.0
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. Day 19 WOMAC Pain Score Change from Baseline	-131.8 units on a scale Interval -338.0 to 75.0	-171.7 units on a scale Interval -388.0 to 21.0	-66.4 units on a scale Interval -289.0 to 72.0
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. Day 64 WOMAC Pain Score Change from Baseline	-79.5 units on a scale Interval -345.0 to 132.0	-169.8 units on a scale Interval -358.0 to 34.0	75.4 units on a scale Interval -291.0 to 107.0
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. Day 94 WOMAC Pain Score Change from Baseline	-111.8 units on a scale Interval -349.0 to 72.0	-147.6 units on a scale Interval -378.0 to 98.0	-80.1 units on a scale Interval -332.0 to 90.0

SECONDARY outcome

Timeframe: 60 minutes after study drug application on Study Days 1,2,3,4

Population: All subjects who have received at least one dose of study drug. The number of subjects analyzed differs in some cases due to missing data.

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.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug. Mean Burning-Stinging Pain on Day 1	1.36 units on a scale Interval 0.0 to 7.75	2.70 units on a scale Interval 0.0 to 7.25	0.36 units on a scale Interval 0.0 to 3.25
Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug. Mean Burning-Stinging Pain on Day 2	0.75 units on a scale Interval 0.0 to 3.75	1.71 units on a scale Interval 0.0 to 7.75	0.49 units on a scale Interval 0.0 to 5.75
Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug. Mean Burning-Stinging Pain Day 3	0.70 units on a scale Interval 0.0 to 3.5	1.53 units on a scale Interval 0.0 to 7.25	0.22 units on a scale Interval 0.0 to 2.5
Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug. Mean Burning-Stinging Pain Day 4	0.56 units on a scale Interval 0.0 to 2.5	1.47 units on a scale Interval 0.0 to 7.0	0.20 units on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4

Population: All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.

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.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores. Day 5 WOMAC Stiffness Score Change from Baseline	-50.7 units on a scale Interval -147.0 to 58.0	-59.6 units on a scale Interval -166.0 to 32.0	-25.6 units on a scale Interval -188.0 to 39.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores. Day 19 WOMAC Stiffness Score Change from Baseline	-52.2 units on a scale Interval -152.0 to 109.0	-65.5 units on a scale Interval -161.0 to 65.0	-26.8 units on a scale Interval -152.0 to 29.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores. Day 35 WOMAC Stiffness Score Change from Baseline	-46.0 units on a scale Interval -154.0 to 78.0	-54.8 units on a scale Interval -137.0 to 33.0	-39.8 units on a scale Interval -158.0 to 30.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores. Day 64 WOMAC Stiffness Score Change from Baseline	-32.2 units on a scale Interval -150.0 to 114.0	-59.5 units on a scale Interval -162.0 to 29.0	-28.1 units on a scale Interval -158.0 to 42.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores. Day 94 WOMAC Stiffness Score Change from Baseline	-42.7 units on a scale Interval -151.0 to 37.0	-56.8 units on a scale Interval -166.0 to 45.0	-31.9 units on a scale Interval -159.0 to 42.0

SECONDARY outcome

Timeframe: Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4

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.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores. Day 5 WOMAC Function Score Change from Baseline	-385.0 units on a scale Interval -1174.0 to 346.0	-499.0 units on a scale Interval -1397.0 to 59.0	-198.1 units on a scale Interval -1343.0 to 223.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores. Day 19 WOMAC Function Score Change from Baseline	-398.7 units on a scale Interval -1275.0 to 501.0	-583.7 units on a scale Interval -1415.0 to 100.0	-192.1 units on a scale Interval -1219.0 to 315.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores. Day 35 WOMAC Function Score Change from Baseline	-367.8 units on a scale Interval -1240.0 to 456.0	-523.0 units on a scale Interval -1397.0 to 286.0	-296.9 units on a scale Interval -1278.0 to 279.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores. Day 64 WOMAC Function Score Change from Baseline	-218.9 units on a scale Interval -1286.0 to 796.0	-515.9 units on a scale Interval -1261.0 to 299.0	-213.7 units on a scale Interval -901.0 to 357.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores. Day 94 WOMAC Function Score Change from Baseline	-337.5 units on a scale Interval -1273.0 to 249.0	-506.5 units on a scale Interval -1406.0 to 191.0	-233 units on a scale Interval -1297.0 to 349.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Study Day 1 through Study Day 35 after the first application of study drug (Study Day 1)

Population: All subjects who have received at least one dose of study drug

Investigator reports of erythema or pruritus at the site of study drug application.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Number of Subjects With Skin Reactions of Erythema or Pruritus. Erythema	1 participants	1 participants	0 participants
Number of Subjects With Skin Reactions of Erythema or Pruritus. Pruritus	2 participants	2 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 35, 64 and 94 day after the last dose of study drug on Study Day 4

Population: All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint.

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.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Number of Subjects With Durability of Efficacy Response Day 35 · Responders	15 Participants	19 Participants	11 Participants
Number of Subjects With Durability of Efficacy Response Day 35 · Non-Responders	25 Participants	22 Participants	29 Participants
Number of Subjects With Durability of Efficacy Response Day 64 Responders · Responders	5 Participants	23 Participants	9 Participants
Number of Subjects With Durability of Efficacy Response Day 64 Responders · Non-Responders	35 Participants	18 Participants	31 Participants
Number of Subjects With Durability of Efficacy Response Day 94 Responders · Responders	10 Participants	18 Participants	10 Participants
Number of Subjects With Durability of Efficacy Response Day 94 Responders · Non-Responders	30 Participants	23 Participants	30 Participants

POST_HOC outcome

Timeframe: Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4

Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index total scores (pain, stiffness and function) from Baseline. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 24 questions relating to pain, stiffness and physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 2400. Positive numbers indicate increases and negative numbers indicate decreases.

Outcome measures

Outcome measures
Measure	CGS-200-1 n=40 Participants 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-200-1: 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.	CGS-200-5 n=42 Participants 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-200-5: 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.	CGS-200 Vehicle n=40 Participants 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function). Day 64 WOMAC Total Score Change from Baseline	-330.6 units on a scale Interval -1781.0 to 901.0	-745.2 units on a scale Interval -1759.0 to 337.0	-317.2 units on a scale Interval -1261.0 to 506.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function). Day 94 WOMAC Total Score Change from Baseline	-491.9 units on a scale Interval -1769.0 to 331.0	-710.8 units on a scale Interval -1939.0 to 314.0	-345.9 units on a scale Interval -1769.0 to 331.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function). Day 5 WOMAC Total Score Change from Baseline	-548.8 units on a scale Interval -1747.0 to 572.0	-716.1 units on a scale Interval -1928.0 to 22.0	-288.1 units on a scale Interval -1940.0 to 285.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function). Day 19 WOMAC Total Score Change from Baseline	-582.8 units on a scale Interval -1747.0 to 572.0	-820.9 units on a scale Interval -1961.0 to 121.0	-285.3 units on a scale Interval -1660.0 to 406.0
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function). Day 35 WOMAC Total Score Change from Baseline	-544.5 units on a scale Interval -1748.0 to 366.0	-737.5 units on a scale Interval -1899.0 to 353.0	-435.8 units on a scale Interval -1747.0 to 370.0

Adverse Events

CGS-200-1

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

CGS-200-5

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

CGS-200 Vehicle

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CGS-200-1 n=40 participants at risk 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-200-1: 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.	CGS-200-5 n=42 participants at risk 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-200-5: 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.	CGS-200 Vehicle n=40 participants at risk；n=42 participants at risk 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. CGS-200 Vehicle: CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
General disorders Application Site Pain	75.0% 30/40 • Number of events 30 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	95.2% 40/42 • Number of events 40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	50.0% 20/40 • Number of events 20 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0
General disorders Application site paraesthesia	5.0% 2/40 • Number of events 2 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	9.5% 4/42 • Number of events 4 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	5.0% 2/40 • Number of events 2 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0
General disorders Application site pruritus	7.5% 3/40 • Number of events 3 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	4.8% 2/42 • Number of events 2 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0
Infections and infestations Nasopharyngitis	5.0% 2/40 • Number of events 2 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	0.00% 0/42 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0
Infections and infestations Upper respiratory tract infection	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	0.00% 0/42 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	5.0% 2/40 • Number of events 2 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0
Injury, poisoning and procedural complications Fall	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	4.8% 2/42 • Number of events 2 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	9.5% 4/42 • Number of events 4 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0	0.00% 0/40 • AEs were captured from start of study drug treatment through Day 94 Severity was graded using the Rheumatology Common Toxicity Criteria (RCTC) version 2.0

Additional Information

Vice President Clinical Operations

Vizuri Health Sciences

Phone: 919-397-4782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor can review results and communications prior to public release, and Sponsor can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the Sponsor for review. At all times, PIs retain editorial control of all publications and have a right to publish the study data, subject only to Sponsor's time-limited right to protect its intellectual property rights and prevent disclosure of Sponsor's confidential information.
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Restriction type: OTHER