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This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with a commercial gel four times daily.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with a commercial gel four times daily. Participants will be evaluated for osteoarthritis by X-ray images of the knees and one knee will be selected for treatment as the target knee. The study gel will be applied directly to that knee throughout the 4 weeks of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMZ001 + Placebo | Experimental | on the target knee |
|
| AMZ001 | Experimental | on the target knee |
|
| Placebo | Placebo Comparator | on the target knee |
|
| Comparator | Active Comparator | Diclofenac gel on the target knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMZ001 | Drug | diclofenac gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Pain Sub-score | 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. | baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Total Score and WOMAC Function and Stiffness | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint (Adverse Events) | Nature, incidence and severity of AEs. | weeks 1 through 4 |
| Skin Tolerability Assessment (Skin Reactions) | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consulting | Milford | Connecticut | 06460 | United States | ||
| Premier Medical Associates |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | AMZ001 BID | on the target knee AMZ001 gel twice daily. BID: Twice a day |
| FG001 | AMZ001 + Placebo QD | on the target knee AMZ001 gel once daily, Placebo gel once daily. QD: Every day/daily |
| FG002 | Placebo BID | on the target knee Placebo gel twice daily. BID: twice a day/ twice daily |
| FG003 | Voltaren 1% QID | on the target knee Voltaren gel 1% applied 4 times a day QID: 4 times every day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AMZ001 BID | on the target knee AMZ001 gel twice daily. BID: twice a day/twice daily |
| BG001 | AMZ001 + Placebo QD | on the target knee AMZ001 gel once daily, Placebo gel once daily. QD: Every day/daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | WOMAC Pain Sub-score | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
4 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMZ001 BID | AMZ001 gel twice daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Amzell B.V. | +41614864000 | amzell-disclosure@amzell.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2019 | Jul 28, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 22, 2018 | Jul 28, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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placebo-controlled, double-blind, randomized, parallel study
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3 treatment arms will be double-blind, the 4th (comparator) will be single-blind
| Placebo |
| Drug |
Placebo |
|
| Comparator | Drug | diclofenac gel |
|
|
| baseline, week 4 |
| WOMAC Pain Weight-bearing Score and Non-weight-bearing Score | 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. | baseline, week 4 |
| ICOAP Scores | 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. | baseline, week 4 |
| Physical Function | 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. | baseline, week 4 |
| Proportion of Responders as Per OMERACT-OARSI Criteria | 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) | week 4 |
| Total Dose of Rescue Medication | Total dose of rescue medication calculated as the average gram use/day, based on pill counts. | weeks 1 through 4 |
| Time Between Baseline and First Use of Rescue Medication | Time between baseline and first use of rescue medication. | weeks 1 through 4 |
| WOMAC Pain Sub-score (Dose Comparison) | 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. | baseline, week 4 |
| ICOAP Scores (Dose Comparison) | 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. | baseline, week 4 |
| WOMAC Pain Weight-bearing Score and Non-weight-bearing Score (Dose Comparison) | 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. | baseline, week 4 |
| Physical Function (Dose Comparison) | 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. | baseline, week 4 |
| WOMAC Total Score and WOMAC Function and Stiffness (Dose Comparison) | 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. | baseline, week 4 |
| Impact of Osteoarthritis on Daily Living (PGA Score) | 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. | baseline, week 4 |
| Work Productivity | 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. | baseline, week 4 |
| Change in Quality of Life: EQ5D VAS Score | 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". | baseline, week 4 |
| week 4 |
| The Villages |
| Florida |
| 32162 |
| United States |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | United States |
| CCR Brno, s.r.o | Brno | Czechia |
| CCR Czech, a.s | Pardubice | Czechia |
| CCR Prague s.r.o. | Prague | Czechia |
| Sanos Clinic | Herlev | Denmark |
| BG002 | Placebo BID | on the target knee Placebo gel twice daily. BID: 2 times a day/ twice a day |
| BG003 | Voltaren 1% QID | on the target knee Voltaren gel 1% applied 4 times a day |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline WOMAC pain sub-score | 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. | Mean | Standard Deviation | score on a scale |
|
| AMZ001 + Placebo QD |
on the target knee AMZ001 gel once daily, Placebo gel once daily. |
| OG002 | Placebo BID | Placebo gel twice daily |
|
|
| Secondary | WOMAC Total Score and WOMAC Function and Stiffness | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | WOMAC Pain Weight-bearing Score and Non-weight-bearing Score | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | ICOAP Scores | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | Physical Function | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | repetitions | baseline, week 4 |
|
|
|
| Secondary | Proportion of Responders as Per OMERACT-OARSI Criteria | 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) | 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. | Posted | Number | 95% Confidence Interval | Proportion of responders | week 4 |
|
|
|
| Secondary | Total Dose of Rescue Medication | Total dose of rescue medication calculated as the average gram use/day, based on pill counts. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | gram/day | weeks 1 through 4 |
|
|
|
| Secondary | Time Between Baseline and First Use of Rescue Medication | Time between baseline and first use of rescue medication. | 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. | Posted | Median | 95% Confidence Interval | Days | weeks 1 through 4 |
|
|
|
| Secondary | WOMAC Pain Sub-score (Dose Comparison) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | ICOAP Scores (Dose Comparison) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | WOMAC Pain Weight-bearing Score and Non-weight-bearing Score (Dose Comparison) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | Physical Function (Dose Comparison) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | repetitions | baseline, week 4 |
|
|
|
| Secondary | WOMAC Total Score and WOMAC Function and Stiffness (Dose Comparison) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | Impact of Osteoarthritis on Daily Living (PGA Score) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | Work Productivity | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of impairment | baseline, week 4 |
|
|
|
| Secondary | Change in Quality of Life: EQ5D VAS Score | 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". | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Other Pre-specified | Safety Endpoint (Adverse Events) | Nature, incidence and severity of AEs. | The SAF (Safety Analysis Set; N=121) was used for safety evaluation of adverse events. | Posted | Count of Participants | Participants | weeks 1 through 4 |
|
|
|
| Other Pre-specified | Skin Tolerability Assessment (Skin Reactions) | 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). | Nature, incidence and severity of AEs. The SAF (Safety Analysis Set; N=121) was used for safety evaluation of adverse events. | Posted | Count of Participants | Participants | week 4 |
|
|
|
| Post-Hoc | WOMAC Pain Sub-score (Subgroup With WOMAC Normalized Pain Sub-score ≥40 at Baseline) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Post-Hoc | WOMAC Total Score and WOMAC Function and Stiffness (Subgroup With WOMAC Normalized Pain Sub-score ≥40 at Baseline) | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| 121 |
| 0 |
| 121 |
| 29 |
| 121 |
| EG001 | AMZ001 + Placebo QD | on the target knee AMZ001 gel once daily, Placebo gel once daily. | 0 | 121 | 0 | 121 | 30 | 121 |
| EG002 | Placebo BID | Placebo gel twice daily | 0 | 121 | 0 | 121 | 52 | 121 |
| EG003 | Voltaren 1% QID | on the target knee Voltaren gel 1% applied 4 times a day | 0 | 121 | 0 | 121 | 11 | 81 |
| Application Site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Application site dryness | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| Change from baseline WOMAC function score |
|
| Change from baseline WOMAC stiffness score |
|
| Change from baseline WOMAC pain non-weight bearing |
|
| ICOAP constant pain score |
|
| ICOAP intermittent pain score |
|
|
| WPAI % Overall work impairment |
|
| WPAI % Activity impairment |
|
| Deaths |
|
| SAEs |
|
| AEs leading to treatment discontinuation |
|
| ADR |
|
| Severity Mild |
|
| Severity Moderate |
|
| Severity Severe |
|
| Questionable erythema not covering entire app site |
|
| Definite erythema not covering entire app site |
|
| Definite erythema and swelling or induration |
|
| Blister formation and/or necrosis |
|
| Change from baseline WOMAC function score |
|
| Change from baseline WOMAC stiffness score |
|