Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Veristat, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with symptomatic OA of the knee.
Each patient's participation is approximately 7 weeks (~1 week screening, 4 weeks of treatment, and 2 weeks of post-treatment follow-up). Eligible patients with adequate OA pain in the index knee are randomized (1:1 allocation ratio) at the Baseline/Flare Visit 1.
Following screening, prior NSAID and/or acetaminophen use is discontinued to allow for washout and symptom flare. Patients are instructed to rate their worst daily and nightly pain in their daily diary, as well as to document all study drug applications and any rescue medication (acetaminophen) use for breakthrough pain. Acetaminophen may be used as rescue medication only, except within 12 hours prior to the Baseline Visit and within 12 hours prior to any post-baseline efficacy assessments (Weeks 2, 4, and 5). Patients are instructed to return to the clinic 3 to 7 days after the last study drug application for Flare Visit 2, and within approximately 2 weeks after the last study drug application for end-of-study evaluations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G001 Topical Gel | Experimental | G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. |
|
| Vehicle Topical Gel | Placebo Comparator | Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G001 Topical Gel | Drug | Non-steroidal anti-inflammatory drug for topical administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT | Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome) | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings | Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome | Week 4 |
| Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Number and percentage of participants with adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation | 6 weeks |
| Frequency and Severity of Application Site AEs |
Inclusion Criteria:
At Baseline:
- Development of a flare of pain following washout of stable analgesic (NSAID and/or acetaminophen) therapy
Exclusion Criteria:
At Baseline:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deirdre O'Keeffe, PhD | Buzzz Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aggarwal and Associates Limited | Brampton | Canada | ||||
| Medicor Research Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Following screening, prior NSAID and/or acetaminophen use was discontinued to allow for washout (3 to 7 days) and symptom flare. Eligible patients with adequate OA pain in the index knee were randomly assigned to G001 or Vehicle in a 1:1 allocation ratio.
The study was conducted at 10 study centers in Canada. A total of 210 patients with OA of the knee were randomly assigned to double-blinded treatment in the study; of these, 105 patients received G001 and 105 patients received Vehicle.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | G001 Topical Gel | G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. G001 Topical Gel: Non-steroidal anti-inflammatory drug for topical administration |
| FG001 | Vehicle Topical Gel | Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. Vehicle: Vehicle Gel for topical administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | G001 Topical Gel | G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. G001 Topical Gel: Non-steroidal anti-inflammatory drug for topical administration |
| BG001 | Vehicle Topical Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT | Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome) | Modified intent-to-treat (mITT) population: All randomized patients who received at least 1 dose of study drug and provided both baseline/Flare Visit 1 (FV1) and Week 4/End-of-Treatment (EOT) efficacy assessments. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 4 |
|
Adverse event (AE) collection period: from the Screening Visit (Day -7 to -3) to the Week 6/End-of-Study (EOS) Visit (Day 43 +/-3). Analyses of AEs were performed for treatment-emergent events (TEAEs), defined as any AE with onset during or after the first application of study drug through the end of the study (Week 6/EOS visit), or any event that was present at Baseline but worsened in severity during or after the first application of study drug.
Adverse events of special interest for G001 included application site adverse reactions.
All AEs occurring between the Screening visit and the Week 6/EOS visit were recorded in the patient's medical record and eCRF.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G001 Topical Gel | G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. G001 Topical Gel: Non-steroidal anti-inflammatory drug for topical administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment | Reported Term: Tachycardic atrial fibrillation Assessed as moderate in intensity, and not related to the (blinded) study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deirdre O'Keefe, PhD, Head of IP and Portfolio Management | Buzzz Pharmaceuticals Limited | +447733104786 | deirdre@hotmail.co.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2022 | Feb 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2023 | Feb 26, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle |
| Drug |
Vehicle Gel for topical administration |
|
Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome |
| Week 4 |
| Percent Reduction From Baseline in Worst Daytime Pain | Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT | Week 4 |
| Percent Reduction From Baseline in Worst Nighttime Pain | Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT | Week 4 |
| Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT | WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome) | Week 4 |
| Change From Baseline in WOMAC Total Score at Week 4/EOT | WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) | Week 4 |
| Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT | WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome) | Week 4 |
| Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | Change from Baseline to Week 2 in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function) | Week 2 |
| Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | Change from Week 4/EOT to Week 5/Flare Visit 2 (FV2) in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function) | Week 4 to Week 5 |
| Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in PGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following:
Worsened - defined as either of the following:
| Weeks 2, 4 and 5 |
| Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in IGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following:
Worsened - defined as either of the following:
| Weeks 2, 4 and 5 |
| PGA of Overall Treatment Benefit (OTB) | PGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome. | Weeks 2 and 4 |
| IGA of Overall Treatment Benefit (OTB) | IGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome. | Weeks 2 and 4 |
| Rescue Medication Use | Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment. | 5 weeks |
| Number of Rescue Medication Doses | Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment. | 5 weeks |
Number and percentage of participants with application site AEs |
| 6 weeks |
| Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | The Numerical Total Score is the sum of the Dermal Response score (from 0=No evidence of irritation to 7=Strong reaction spreading beyond the application site) and the numeric equivalent of Other Effects score (from 0=Slightly glazed appearance to 3=Small petechial erosions and/or scabs). The Numerical Total Score range is from 0 to 10, with higher scores indicating worse outcome/skin irritation. | Weeks 2, 4, and 6 |
| ECG Abnormalities in QT, QTc, QRS, or PR Intervals | Number and percentage of participants with clinically significant (CS) abnormal results in QT, QTc, QRS, or PR intervals at Week 4/EOT | 4 weeks |
| Changes From Baseline in Safety Laboratory Test Results | Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges | 6 weeks |
| Changes in Vital Signs Measurements | Mean changes (descriptive) from baseline | 6 weeks |
| Changes in Physical Examination | Number and percentage of participants with clinically significant abnormal findings | 6 weeks |
| Greater Sudbury |
| Canada |
| Manna Research | Lévis | Canada |
| Recherche GCP Research | Montreal | Canada |
| Alpha recherche Clinique (1) | Québec | Canada |
| Alpha Recherche Clinique (2) | Québec | Canada |
| Centre de Recherche Saint-Louis | Québec | Canada |
| G.R.M.O. (Groupe de Recherche en Maladie Osseuses) Inc. | Québec | Canada |
| Recherche Clinique Sigma Inc. | Québec | Canada |
| Canadian Phase Onward Inc. | Toronto | Canada |
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Worst daily pain (11-point NRS), Index knee | 11-point Numerical Rating Scale (NRS) Scores ranging from 0 to 10, with higher scores indicating worse pain. | Mean | Standard Deviation | Score on a scale |
|
| Worst daily pain (11-point NRS), Contralateral knee | 11-point Numerical Rating Scale (NRS) Scores ranging from 0 to 10, with higher scores indicating worse pain. | Mean | Standard Deviation | Score on a scale |
|
| Kellgren and Lawrence Grading | Kellgren and Lawrence Radiographic Grading (0 to 4, with higher grades indicating worse OA severity): Grade 0: No radiographic features of osteoarthritis are present; Grade 1: Doubtful joint space narrowing (JSN) and possible osteophytic lipping; Grade 2: Presence of definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph; Grade 3: Multiple osteophytes, definite JSN, sclerosis, possible bony deformity; Grade 4: Large osteophytes, marked JSN, severe sclerosis and definitely bony deformity. | Count of Participants | Participants |
|
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. Vehicle: Vehicle Gel for topical administration |
|
|
|
| Secondary | Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings | Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome | mITT Population | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Secondary | Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings | Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome | mITT Population | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Secondary | Percent Reduction From Baseline in Worst Daytime Pain | Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT | mITT | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Percent Reduction From Baseline in Worst Nighttime Pain | Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT | mITT Population | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT | WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome) | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 4 |
|
|
|
| Secondary | Change From Baseline in WOMAC Total Score at Week 4/EOT | WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 4 |
|
|
|
| Secondary | Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT | WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome) | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 4 |
|
|
|
| Secondary | Change From Baseline in WOMAC Total and Subscale Scores at Week 2 | Change from Baseline to Week 2 in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function) | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 2 |
|
|
|
| Secondary | Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores | Change from Week 4/EOT to Week 5/Flare Visit 2 (FV2) in: WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function) | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 4 to Week 5 |
|
|
|
| Secondary | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time | PGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in PGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following:
Worsened - defined as either of the following:
| mITT | Posted | Count of Participants | Participants | Weeks 2, 4 and 5 |
|
|
|
| Secondary | Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time | IGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome. Change from Baseline in IGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules: Improved - defined as either of the following:
Worsened - defined as either of the following:
| mITT Population | Posted | Count of Participants | Participants | Weeks 2, 4 and 5 |
|
|
|
| Secondary | PGA of Overall Treatment Benefit (OTB) | PGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome. | mITT Population | Posted | Count of Participants | Participants | Weeks 2 and 4 |
|
|
|
| Secondary | IGA of Overall Treatment Benefit (OTB) | IGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome. | mITT Population | Posted | Count of Participants | Participants | Weeks 2 and 4 |
|
|
|
| Secondary | Rescue Medication Use | Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment. | mITT Population | Posted | Mean | Standard Deviation | mg/day | 5 weeks |
|
|
|
| Other Pre-specified | Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation | Number and percentage of participants with adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation | Safety Population | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Other Pre-specified | Frequency and Severity of Application Site AEs | Number and percentage of participants with application site AEs | Safety Population | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Other Pre-specified | Skin Irritation Test Scores (Berger/Bowman Scoring Scale) | The Numerical Total Score is the sum of the Dermal Response score (from 0=No evidence of irritation to 7=Strong reaction spreading beyond the application site) and the numeric equivalent of Other Effects score (from 0=Slightly glazed appearance to 3=Small petechial erosions and/or scabs). The Numerical Total Score range is from 0 to 10, with higher scores indicating worse outcome/skin irritation. | Safety Population | Posted | Count of Participants | Participants | Weeks 2, 4, and 6 |
|
|
|
| Other Pre-specified | ECG Abnormalities in QT, QTc, QRS, or PR Intervals | Number and percentage of participants with clinically significant (CS) abnormal results in QT, QTc, QRS, or PR intervals at Week 4/EOT | Safety Population | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Other Pre-specified | Changes From Baseline in Safety Laboratory Test Results | Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges | Not Posted | 6 weeks | Participants |
| Other Pre-specified | Changes in Vital Signs Measurements | Mean changes (descriptive) from baseline | Not Posted | 6 weeks | Participants |
| Other Pre-specified | Changes in Physical Examination | Number and percentage of participants with clinically significant abnormal findings | Not Posted | 6 weeks | Participants |
| Secondary | Number of Rescue Medication Doses | Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment. | mITT Population | Posted | Mean | Standard Deviation | number of doses | 5 weeks |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 10 |
| 105 |
| EG001 | Vehicle Topical Gel | Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. Vehicle: Vehicle Gel for topical administration | 0 | 105 | 1 | 105 | 5 | 105 |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| ≥ 50% Reduction from BL |
|
| ≥ 50% Reduction from BL |
|
| WOMAC Stiffness score, Change from BL to Week 2 |
|
| WOMAC Physical Function score, Change from BL to Week 2 |
|
| WOMAC Stiffness score, Change from Week 4/EOT to Week 5/FV2 |
|
| WOMAC Physical Function score, Change from Week 4/EOT to Week 5/FV2 |
|
| No change |
|
| Worsened |
|
| PGA of DA, Change from BL to Week 4 |
|
|
| PGA of DA, Change from BL to Week 5 |
|
|
| No Change |
|
| Worsened |
|
| IGA of DA, Change from BL to Week 4 |
|
|
| IGA of DA, Change from BL to Week 5 |
|
|
| Fair |
|
| Poor or Very Poor |
|
| PGA of OTB at Week 4 |
|
|
| Fair |
|
| Poor or Very Poor |
|
| IGA of OTB, Week 4 |
|
|
| Any SAE |
|
| Any TEAE leading to Discontinuation |
|
| Numerical Total Score of 1 |
|
| Numerical Total Score of ≥2 |
|
| Skin Irritation Total Score, Week 4/EOT |
|
|
| Skin Irritation Total Score, Week 6 |
|
|
| CS QRS Interval abnormality |
|
| CS PR Interval abnormality |
|