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AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691844
Recruitment Status : Completed
First Posted : October 2, 2018
Results First Posted : October 6, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Amzell

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Interventions Drug: AMZ001
Drug: Placebo
Drug: Comparator
Enrollment 444
Recruitment Details

Seven trial sites in Denmark (1 site), Czech Republic (3 sites) and the USA (3 sites).

Trial initiation: 04-Oct-2018 Trial completion: 09-Jul-2019

Pre-assignment Details  
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Hide Arm/Group Description

on the target knee

AMZ001 gel twice daily.

BID: Twice a day

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

QD: Every day/daily

on the target knee

Placebo gel twice daily.

BID: twice a day/ twice daily

on the target knee

Voltaren gel 1% applied 4 times a day

QID: 4 times every day

Period Title: Overall Study
Started 121 121 121 81
Completed 114 109 108 70
Not Completed 7 12 13 11
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID Total
Hide Arm/Group Description

on the target knee

AMZ001 gel twice daily.

BID: twice a day/twice daily

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

QD: Every day/daily

on the target knee

Placebo gel twice daily.

BID: 2 times a day/ twice a day

on the target knee

Voltaren gel 1% applied 4 times a day

Total of all reporting groups
Overall Number of Baseline Participants 121 121 121 81 444
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 121 participants 81 participants 444 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
  49.6%
55
  45.5%
62
  51.2%
39
  48.1%
216
  48.6%
>=65 years
61
  50.4%
66
  54.5%
59
  48.8%
42
  51.9%
228
  51.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 121 participants 81 participants 444 participants
Female
83
  68.6%
83
  68.6%
77
  63.6%
54
  66.7%
297
  66.9%
Male
38
  31.4%
38
  31.4%
44
  36.4%
27
  33.3%
147
  33.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 121 participants 81 participants 444 participants
Hispanic or Latino
1
   0.8%
0
   0.0%
3
   2.5%
1
   1.2%
5
   1.1%
Not Hispanic or Latino
120
  99.2%
121
 100.0%
118
  97.5%
80
  98.8%
439
  98.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 121 participants 81 participants 444 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%
1
   0.8%
2
   1.7%
0
   0.0%
3
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.2%
Black or African American
6
   5.0%
1
   0.8%
4
   3.3%
3
   3.7%
14
   3.2%
White
115
  95.0%
119
  98.3%
115
  95.0%
77
  95.1%
426
  95.9%
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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline WOMAC pain sub-score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 121 participants 121 participants 121 participants 81 participants 444 participants
28.2  (6.07) 27.5  (5.24) 27.1  (4.82) 27.3  (5.48) 27.5  (5.41)
[1]
Measure Description: Baseline scores in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 [no pain]-50 [extreme pain]) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where higher scores indicates greater pain.
1.Primary Outcome
Title WOMAC Pain Sub-score
Hide Description Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 [no pain]-50 [extreme pain]) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:
AMZ001 gel twice daily

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Placebo gel twice daily
Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-26.49
(-29.6 to -23.38)
-27.33
(-30.5 to -24.17)
-22.73
(-25.90 to -19.55)
2.Secondary Outcome
Title WOMAC Total Score and WOMAC Function and Stiffness
Hide Description Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) total score and WOMAC function (degree of difficulty experienced in performing daily activities - 17 questions score 0-170) and stiffness (the degree and timing of joint stiffness - 2 questions score 0-20). The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Change from baseline WOMAC total score
-24.15
(-26.95 to -21.34)
-23.32
(-26.16 to -20.47)
-20.57
(-23.42 to -17.72)
Change from baseline WOMAC function score
-23.43
(-26.29 to -20.58)
-22.30
(-25.19 to -19.40)
-19.94
(-22.84 to -17.04)
Change from baseline WOMAC stiffness score
-23.17
(-26.42 to -19.93)
-23.35
(-26.66 to -20.05)
-20.65
(-23.96 to -17.34)
3.Secondary Outcome
Title WOMAC Pain Weight-bearing Score and Non-weight-bearing Score
Hide Description Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain weight-bearing score (questions 1,2, & 5; score 0-30) and non-weight-bearing score (questions 3&4; score 0-20) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Change from baseline WOMAC pain weight bearing
-27.03
(-30.36 to -23.70)
-27.68
(-31.07 to -24.30)
-22.65
(-26.04 to -19.25)
Change from baseline WOMAC pain non-weight bearing
-25.65
(-28.87 to -22.44)
-26.89
(-30.17 to -23.61)
-22.93
(-26.22 to -19.65)
4.Secondary Outcome
Title ICOAP Scores
Hide Description Change from baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) scores (score 0 [no pain]- 4 [extreme pain]). ICOAP scores were normalized to a 0-100 point scale, where 0 is no pain and higher scores indicate greater pain.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
ICOAP total score
-20.62
(-23.40 to -17.84)
-18.87
(-21.72 to -16.02)
-17.98
(-20.83 to -15.13)
ICOAP constant pain score
-20.82
(-23.91 to -17.73)
-19.01
(-22.18 to -15.83)
-18.37
(-21.54 to -15.19)
ICOAP intermittent pain score
-20.18
(-23.19 to -17.17)
-19.00
(-22.09 to -15.92)
-17.99
(-21.08 to -14.90)
5.Secondary Outcome
Title Physical Function
Hide Description Change in baseline in physical function assessed by the chair-stand test. The test measures the maximum number of chair stand repetitions possible in a 30-second period with out using the arms. Where 0 is no repetition completed and higher numbers corresponds to greater repetitions and physical function.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: repetitions
2.41
(1.98 to 2.83)
2.30
(1.87 to 2.72)
2.37
(1.94 to 2.80)
6.Secondary Outcome
Title Proportion of Responders as Per OMERACT-OARSI Criteria
Hide Description Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI) response involves changes that are deemed to be clinically relevant in three domains: pain, function, and PGA (Patient Global Assessment). For each of these domains, ranges are defined for absolute and percent changes from baseline that correspond to "high improvement" and "moderate improvement". OMERACT-OARSI response is defined as either high improvement in at least 1 of WOMAC pain and function scores OR moderate improvement in at least 2 of WOMAC pain scores, WOMAC function score or Patient Global Assessment (PGA)
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 115 109 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of responders
0.765
(0.679 to 0.834)
0.826
(.0743 to 0.886)
0.725
(0.634 to 0.800)
7.Secondary Outcome
Title Total Dose of Rescue Medication
Hide Description Total dose of rescue medication calculated as the average gram use/day, based on pill counts.
Time Frame weeks 1 through 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: gram/day
0.27
(0.19 to 0.36)
0.31
(0.22 to 0.40)
0.30
(0.21 to 0.39)
8.Secondary Outcome
Title Time Between Baseline and First Use of Rescue Medication
Hide Description Time between baseline and first use of rescue medication.
Time Frame weeks 1 through 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Median (95% Confidence Interval)
Unit of Measure: Days
17
(7.0 to 24.0)
9
(5.0 to 15.0)
10
(4.0 to 17.0)
9.Secondary Outcome
Title WOMAC Pain Sub-score (Dose Comparison)
Hide Description Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 [no pain]-50 [extreme pain]) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Overall Number of Participants Analyzed 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-26.49
(-29.60 to -23.38)
-27.33
(-30.5 to -24.17)
10.Secondary Outcome
Title ICOAP Scores (Dose Comparison)
Hide Description Change from baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) scores (score 0 [no pain]- 4 [extreme pain]). ICOAP scores were normalized to a 0-100 point scale, where 0 is no pain and higher scores indicate greater pain.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Overall Number of Participants Analyzed 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-20.62
(-23.40 to -17.84)
-18.87
(-21.72 to -16.02)
11.Secondary Outcome
Title WOMAC Pain Weight-bearing Score and Non-weight-bearing Score (Dose Comparison)
Hide Description Changes from baseline in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain weight-bearing score (questions 1,2, & 5; score 0-30) and non-weight-bearing score (questions 3&4; score 0-20) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Overall Number of Participants Analyzed 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Weight-bearing
-27.03
(-30.36 to -23.70)
-27.68
(-31.07 to -24.30)
Non-weight-bearing
-25.65
(-28.87 to -22.44)
-26.89
(-30.17 to -23.61)
12.Secondary Outcome
Title Physical Function (Dose Comparison)
Hide Description Change in baseline assessed by the chair-stand test. The test measures the maximum number of chair stand repetitions possible in a 30-second period with out using the arms. Where 0 is no repetition completed and higher numbers corresponds to greater repetitions and physical function.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Overall Number of Participants Analyzed 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: repetitions
2.41
(1.98 to 2.83)
2.3
(1.87 to 2.72)
13.Secondary Outcome
Title WOMAC Total Score and WOMAC Function and Stiffness (Dose Comparison)
Hide Description Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) total score and WOMAC function (degree of difficulty experienced in performing daily activities - 17 questions score 0-170) and stiffness (the degree and timing of joint stiffness - 2 questions score 0-20). The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Overall Number of Participants Analyzed 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Function
-23.43
(-26.29 to -20.58)
-22.30
(-25.19 to -19.40)
Stiffness
-23.17
(-26.42 to -19.93)
-23.35
(-26.66 to -20.05)
14.Secondary Outcome
Title Impact of Osteoarthritis on Daily Living (PGA Score)
Hide Description Change from baseline in Impact of OA daily living assessed using Patient Global Assessment (PGA) score. PGA is scored on a 11-point scale from 0 (none) to 10 (extreme), where higher scores represents a higher level of disease activity or worse health.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-2.29
(-2.63 to -1.94)
-2.31
(-2.66 to -1.96)
-1.68
(-2.03 to -1.32)
15.Secondary Outcome
Title Work Productivity
Hide Description Change from baseline in work productivity and activity assessed by the Work Productivity and Active Impairment (WPAI scores 0-100% in four different categories: absenteeism, presenteeism, work productivity loss, and activity impairment). Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 45 41 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of impairment
WPAI % Time missed
0.39
(-2.73 to 3.51)
-3.10
(-6.43 to 0.23)
1.58
(-2.01 to 5.16)
WPAI % Impairment while working
-13.11
(-18.71 to -7.51)
-14.38
(-20.57 to -8.79)
-5.28
(-12.26 to 1.70)
WPAI % Overall work impairment
-11.69
(-17.95 to -5.43)
-16.93
(-23.95 to -9.91)
-6.50
(-14.19 to 1.20)
WPAI % Activity impairment
-17.75
(-21.45 to -14.06)
-20.41
(-24.15 to -16.68)
-13.03
(-16.79 to -9.27)
16.Secondary Outcome
Title Change in Quality of Life: EQ5D VAS Score
Hide Description The EuroQol-5 Domain (EQ-5D) is a standardized generic measure of health-related quality of life. The visual analog scale (VAS) is scored on a 0-100 scale, where 0 is "the worst health you can imagine" and 100, "the best health you can imagine".
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT (modified Intent to treat; N=120) population set includes subjects with a baseline and at least one post-treatment WOMAC pain sub-score and was used in statistical analysis for primary and secondary endpoint outcome measures.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 120 120 120
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
13.04
(10.13 to 15.94)
11.76
(8.82 to 14.71)
8.34
(5.39 to 11.28)
17.Other Pre-specified Outcome
Title Safety Endpoint (Adverse Events)
Hide Description Nature, incidence and severity of AEs.
Time Frame weeks 1 through 4
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF (Safety Analysis Set; N=121) was used for safety evaluation of adverse events.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

on the target knee Voltaren gel 1% applied 4 times a day QID: 4 times every day
Overall Number of Participants Analyzed 121 121 121 81
Measure Type: Count of Participants
Unit of Measure: Participants
All TEAEs
51
  42.1%
53
  43.8%
75
  62.0%
26
  32.1%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AEs leading to treatment discontinuation
3
   2.5%
8
   6.6%
7
   5.8%
5
   6.2%
ADR
29
  24.0%
29
  24.0%
51
  42.1%
9
  11.1%
Severity Mild
39
  32.2%
45
  37.2%
66
  54.5%
20
  24.7%
Severity Moderate
17
  14.0%
11
   9.1%
14
  11.6%
9
  11.1%
Severity Severe
0
   0.0%
0
   0.0%
1
   0.8%
1
   1.2%
18.Other Pre-specified Outcome
Title Skin Tolerability Assessment (Skin Reactions)
Hide Description Skin tolerability assessment, incidence of erythema at the application site. Grading scheme from 0-4 (0, normal skin, no erythema; 4, blister formation and/or necrosis).
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Nature, incidence and severity of AEs. The SAF (Safety Analysis Set; N=121) was used for safety evaluation of adverse events.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

on the target knee Voltaren gel 1% applied 4 times a day QID: 4 times every day
Overall Number of Participants Analyzed 121 121 121 81
Measure Type: Count of Participants
Unit of Measure: Participants
Normal skin; no erythema
100
  82.6%
89
  73.6%
79
  65.3%
68
  84.0%
Questionable erythema not covering entire app site
14
  11.6%
18
  14.9%
20
  16.5%
3
   3.7%
Definite erythema not covering entire app site
2
   1.7%
2
   1.7%
10
   8.3%
0
   0.0%
Definite erythema and swelling or induration
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Blister formation and/or necrosis
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
19.Post-Hoc Outcome
Title WOMAC Pain Sub-score (Subgroup With WOMAC Normalized Pain Sub-score ≥40 at Baseline)
Hide Description Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 [no pain]-50 [extreme pain]) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Post-hoc statistical analyses were performed for the comparison of each of the AMZ001 regimens vs placebo and between the two AMZ001 regimens. Sub-group of subjects meeting the WOMAC pain sub-score inclusion criterion at both screening and baseline.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 109 107 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-28.54
(-31.87 to -25.20)
-29.02
(-32.45 to -25.60)
-23.18
(-26.64 to -19.72)
20.Post-Hoc Outcome
Title WOMAC Total Score and WOMAC Function and Stiffness (Subgroup With WOMAC Normalized Pain Sub-score ≥40 at Baseline)
Hide Description Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) total score and WOMAC function (degree of difficulty experienced in performing daily activities - 17 questions score 0-170) and stiffness (the degree and timing of joint stiffness - 2 questions score 0-20) . The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Post-hoc statistical analyses were performed for the comparison of each of the AMZ001 regimens vs placebo and between the two AMZ001 regimens. Sub-group of subjects meeting the WOMAC pain sub-score inclusion criterion at both screening and baseline.
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID
Hide Arm/Group Description:

on the target knee

AMZ001 gel twice daily.

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

on the target knee

Placebo gel twice daily.

Overall Number of Participants Analyzed 109 107 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Change from baseline WOMAC total score
-25.54
(-28.54 to -22.54)
-24.03
(-27.11 to -20.95)
-20.61
(-23.71 to -17.51)
Change from baseline WOMAC function score
-24.69
(-27.75 to -21.64)
-22.84
(-25.97 to -19.70)
-19.84
(-23.00 to -16.68)
Change from baseline WOMAC stiffness score
-24.08
(-27.52 to -20.64)
-23.57
(-27.11 to -20.03)
-20.33
(-23.89 to -16.76)
Time Frame 4 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Hide Arm/Group Description AMZ001 gel twice daily

on the target knee

AMZ001 gel once daily, Placebo gel once daily.

Placebo gel twice daily

on the target knee

Voltaren gel 1% applied 4 times a day

All-Cause Mortality
AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)      0/121 (0.00%)      0/121 (0.00%)      0/121 (0.00%)    
Hide Serious Adverse Events
AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/121 (0.00%)      0/121 (0.00%)      0/121 (0.00%)      0/121 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AMZ001 BID AMZ001 + Placebo QD Placebo BID Voltaren 1% QID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/121 (23.97%)      30/121 (24.79%)      52/121 (42.98%)      11/81 (13.58%)    
General disorders         
Application Site erythema  1  11/121 (9.09%)  12 15/121 (12.40%)  16 40/121 (33.06%)  41 4/81 (4.94%)  4
Application site dryness  1  18/121 (14.88%)  18 13/121 (10.74%)  13 16/121 (13.22%)  16 5/81 (6.17%)  5
Application site pruritus  1  5/121 (4.13%)  5 8/121 (6.61%)  8 6/121 (4.96%)  6 2/81 (2.47%)  3
Infections and infestations         
Nasopharyngitis  1  6/121 (4.96%)  7 3/121 (2.48%)  3 6/121 (4.96%)  6 4/81 (4.94%)  5
Nervous system disorders         
Headache  1  2/121 (1.65%)  3 1/121 (0.83%)  2 8/121 (6.61%)  9 0/81 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Manager
Organization: Amzell B.V.
Phone: +41614864000
EMail: amzell-disclosure@amzell.com
Layout table for additonal information
Responsible Party: Amzell
ClinicalTrials.gov Identifier: NCT03691844    
Other Study ID Numbers: AMZ001-006
First Submitted: September 18, 2018
First Posted: October 2, 2018
Results First Submitted: July 30, 2020
Results First Posted: October 6, 2020
Last Update Posted: October 6, 2020