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

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ClinicalTrials.gov Identifier: NCT03124407
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : March 30, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Palm Beach Research, Inc
Information provided by (Responsible Party):
Propella Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Interventions Drug: Capsaicin Topical Solution
Other: Drug product vehicle
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QD-Active QD-Vehicle BID-Active BID-Vehicle
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 40 20 40 20
Completed 39 20 39 20
Not Completed 1 0 1 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
Adverse Event             0             0             1             0
Arm/Group Title Once Daily-Active Once Daily-Vehicle Twice Daily-Active Twice Daily-Vehicle Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 40 20 40 20 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 20 participants 40 participants 20 participants 120 participants
58.0
(35 to 90)
55.2
(38 to 75)
56.7
(36 to 74)
56.5
(35 to 72)
56.6
(35 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 40 participants 20 participants 120 participants
Female
26
  65.0%
10
  50.0%
27
  67.5%
10
  50.0%
73
  60.8%
Male
14
  35.0%
10
  50.0%
13
  32.5%
10
  50.0%
47
  39.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 40 participants 20 participants 120 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  40.0%
8
  40.0%
15
  37.5%
7
  35.0%
46
  38.3%
White
24
  60.0%
11
  55.0%
25
  62.5%
11
  55.0%
71
  59.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
2
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 20 participants 40 participants 20 participants 120 participants
40 20 40 20 120
BMI (kg/m2)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 20 participants 40 participants 20 participants 120 participants
29.6
(20 to 39)
28.9
(23 to 39)
30.5
(19 to 40)
29
(19 to 39)
29.5
(19 to 40)
1.Primary Outcome
Title Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to 24 Hours After First Dose of Study Drug Treatment.
Hide Description 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.
Time Frame Study Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all subjects who received at least one application of study drug and reported a pain score on Study Day 2.
Arm/Group Title Once Daily-Active Once Daily-Vehicle Twice Daily-Active Twice Daily-Vehicle
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 37 20 39 20
Measure Type: Number
Unit of Measure: percentage of subjects
27.03 20.0 23.08 20.0
2.Secondary Outcome
Title Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 8 Post Study Drug Treatment.
Hide Description 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.
Time Frame Study Days 1-7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all subjects who received at least one application of study drug and reported pain scores during Study Days 1-7.
Arm/Group Title Once Daily-Active Once Daily-Vehicle Twice Daily-Active Twice Daily-Vehicle
Hide Arm/Group Description:

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

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 without capsaicin

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

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 without capsaicin

Overall Number of Participants Analyzed 38 20 38 20
Measure Type: Number
Unit of Measure: percentage of subjects
42.11 25 47.37 40
3.Secondary Outcome
Title Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 28 Post Study Drug Treatment.
Hide Description 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.
Time Frame Study Days 1-28
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all subjects who received at least one application of study drug and reported any pain scores during the study.
Arm/Group Title Once Daily-Active Once Daily-Vehicle Twice Daily-Active Twice Daily-Vehicle
Hide Arm/Group Description:

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

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 without capsaicin

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

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 without capsaicin

Overall Number of Participants Analyzed 40 20 40 20
Measure Type: Number
Unit of Measure: percentage of subjects
53.85 26.32 57.89 47.37
Time Frame Adverse events were collected from the start of study drug treatment (Day 1) to the end of treatment (Day 28).
Adverse Event Reporting Description 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.
 
Arm/Group Title QD-Active QD-Vehicle BID-Active BID-Vehicle
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
QD-Active QD-Vehicle BID-Active BID-Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/20 (0.00%)   0/40 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
QD-Active QD-Vehicle BID-Active BID-Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/20 (0.00%)   0/40 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
QD-Active QD-Vehicle BID-Active BID-Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/40 (65.00%)   9/20 (45.00%)   35/40 (87.50%)   13/20 (65.00%) 
General disorders         
Application site pruritus   7/40 (17.50%)  4/20 (20.00%)  5/40 (12.50%)  1/20 (5.00%) 
Application site erythema   1/40 (2.50%)  0/20 (0.00%)  13/40 (32.50%)  1/20 (5.00%) 
Application site pain   26/40 (65.00%)  6/20 (30.00%)  34/40 (85.00%)  12/20 (60.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Clinical Operations
Organization: Vizuri Health Sciences
Phone: 919-397-4782
EMail: twarneke@vizuriusa.com
Layout table for additonal information
Responsible Party: Propella Therapeutics
ClinicalTrials.gov Identifier: NCT03124407    
Other Study ID Numbers: VZU-00022
First Submitted: April 18, 2017
First Posted: April 21, 2017
Results First Submitted: March 13, 2020
Results First Posted: March 30, 2020
Last Update Posted: October 8, 2020