Trial Outcomes & Findings for Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200 (NCT NCT03124407)

NCT ID: NCT03124407

Last Updated: 2024-10-31

Results Overview

To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline at 24 hours following the first study drug treatment. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: Study Day 2
• Results posted on: 2024-10-31

Participant Flow

Participant milestones

Measure	QD-Active 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin	QD-Vehicle 20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product	BID-Active 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin	BID-Vehicle 20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product
Overall Study STARTED	40	20	40	20
Overall Study COMPLETED	39	20	39	20
Overall Study NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Measure	QD-Active 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin	QD-Vehicle 20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product	BID-Active 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin	BID-Vehicle 20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Adverse Event	0	0	1	0

Baseline Characteristics

Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200

Baseline characteristics by cohort

Measure	Once Daily-Active n=40 Participants 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Once Daily-Vehicle n=20 Participants 20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin	Twice Daily-Active n=40 Participants 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Twice Daily-Vehicle n=20 Participants 20 subjects receiving twice daily application of drug product vehicle (i.e. ,with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin	Total n=120 Participants Total of all reporting groups
Age, Continuous	58.0 years n=5 Participants	55.2 years n=7 Participants	56.7 years n=5 Participants	56.5 years n=4 Participants	56.6 years n=21 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants	10 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	47 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	46 Participants n=21 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants	11 Participants n=4 Participants	71 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	40 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants	20 participants n=4 Participants	120 participants n=21 Participants
BMI (kg/m2)	29.6 kg/m^2 n=5 Participants	28.9 kg/m^2 n=7 Participants	30.5 kg/m^2 n=5 Participants	29 kg/m^2 n=4 Participants	29.5 kg/m^2 n=21 Participants

PRIMARY outcome

Timeframe: Study Day 2

Population: The analysis population included all subjects who received at least one application of study drug and reported a pain score on Study Day 2.

To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline at 24 hours following the first study drug treatment. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.

Outcome measures

Measure	Once Daily-Active n=37 Participants 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Once Daily-Vehicle n=20 Participants 20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin	Twice Daily-Active n=39 Participants 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Twice Daily-Vehicle n=20 Participants 20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin
Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to 24 Hours After First Dose of Study Drug Treatment.	27.03 percentage of subjects	20.0 percentage of subjects	23.08 percentage of subjects	20.0 percentage of subjects

SECONDARY outcome

Timeframe: Study Days 1-7

Population: The analysis population included all subjects who received at least one application of study drug and reported pain scores during Study Days 1-7.

To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline after a 7 day period. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.

Outcome measures

Measure	Once Daily-Active n=38 Participants 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Once Daily-Vehicle n=20 Participants 20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin	Twice Daily-Active n=38 Participants 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Twice Daily-Vehicle n=20 Participants 20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin
Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 8 Post Study Drug Treatment.	42.11 percentage of subjects	25 percentage of subjects	47.37 percentage of subjects	40 percentage of subjects

SECONDARY outcome

Timeframe: Study Days 1-28

Population: The analysis population included all subjects who received at least one application of study drug and reported any pain scores during the study.

To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline after 28 days. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.

Outcome measures

Measure	Once Daily-Active n=40 Participants 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Once Daily-Vehicle n=20 Participants 20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin	Twice Daily-Active n=40 Participants 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin	Twice Daily-Vehicle n=20 Participants 20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product, but with no capsaicin
Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 28 Post Study Drug Treatment.	53.85 percentage of subjects	26.32 percentage of subjects	57.89 percentage of subjects	47.37 percentage of subjects

Adverse Events

QD-Active

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

QD-Vehicle

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

BID-Active

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

BID-Vehicle

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	QD-Active n=40 participants at risk 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin	QD-Vehicle n=20 participants at risk 20 subjects receiving once daily application of drug product vehicle (i.e.. with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product	BID-Active n=40 participants at risk 40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee Capsaicin Topical Solution: OTC Tentative Final Monograph (TFM) compliant product with 0.25% capsaicin	BID-Vehicle n=20 participants at risk 20 subjects receiving twice daily application of drug product vehicle (i.e.. with no capsaicin) to the knee Drug product vehicle: This is the vehicle for the active treatment drug product
General disorders Application site pruritus	17.5% 7/40 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	20.0% 4/20 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	12.5% 5/40 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	5.0% 1/20 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.
General disorders Application site erythema	2.5% 1/40 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	0.00% 0/20 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	32.5% 13/40 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	5.0% 1/20 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.
General disorders Application site pain	65.0% 26/40 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	30.0% 6/20 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	85.0% 34/40 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.	60.0% 12/20 • Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28). Definition of adverse events were consistent with clinicaltrials.gov definitions. Application site adverse events were specifically collected at pre-application of study drug (-30 min (± 5 min), and at 15 (± 5 min), 30 (± 5 min), 45 (± 5 min), and 60 minutes (± 5 min) and after leaving the clinic on each day at home at the same time (± 2 hours) for 7 days.

Additional Information

Vice President Clinical Operations

Vizuri Health Sciences

Phone: 919-397-4782

Email: twarneke@vizuriusa.com

Results disclosure agreements

• Principal investigator is a sponsor employee No disclosure of any of the data and results of this STUDY by way of publication or otherwise, shall be made by RESEARCH CENTER, or any third party, without the prior written consent of VIZURI.
• Publication restrictions are in place

Restriction type: OTHER