Trial Outcomes & Findings for Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee (NCT NCT05007808)
NCT ID: NCT05007808
Last Updated: 2024-04-23
Results Overview
Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
Week 4
Results posted on
2024-04-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
105
|
|
Overall Study
COMPLETED
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Baseline characteristics by cohort
| Measure |
G001 Topical Gel
n=105 Participants
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
|
Vehicle Topical Gel
n=105 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 7.89 • n=99 Participants
|
65.3 years
STANDARD_DEVIATION 8.35 • n=107 Participants
|
64.8 years
STANDARD_DEVIATION 8.12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
209 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
105 participants
n=99 Participants
|
105 participants
n=107 Participants
|
210 participants
n=206 Participants
|
|
Worst daily pain (11-point NRS), Index knee
|
6.8 Score on a scale
STANDARD_DEVIATION 1.29 • n=99 Participants
|
6.4 Score on a scale
STANDARD_DEVIATION 1.39 • n=107 Participants
|
6.6 Score on a scale
STANDARD_DEVIATION 1.35 • n=206 Participants
|
|
Worst daily pain (11-point NRS), Contralateral knee
|
1.1 Score on a scale
STANDARD_DEVIATION 0.78 • n=99 Participants
|
0.9 Score on a scale
STANDARD_DEVIATION 0.81 • n=107 Participants
|
1.0 Score on a scale
STANDARD_DEVIATION 0.80 • n=206 Participants
|
|
Kellgren and Lawrence Grading
KL Grade 2
|
46 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Kellgren and Lawrence Grading
KL Grade 3
|
59 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: 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.
Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome)
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT
|
-5.4 score on a scale
Standard Error 0.32
|
-5.2 score on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population
Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings
|
-2.1 score on a scale
Standard Deviation 2.01
|
-2.0 score on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population
Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=103 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings
|
-2.1 score on a scale
Standard Deviation 2.01
|
-1.9 score on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: Week 4Population: mITT
Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=103 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Percent Reduction From Baseline in Worst Daytime Pain
≥ 20% Reduction from BL
|
70 Participants
|
68 Participants
|
|
Percent Reduction From Baseline in Worst Daytime Pain
≥ 30% Reduction from BL
|
58 Participants
|
53 Participants
|
|
Percent Reduction From Baseline in Worst Daytime Pain
≥ 50% Reduction from BL
|
35 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population
Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=103 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Percent Reduction From Baseline in Worst Nighttime Pain
≥ 20% Reduction from BL
|
73 Participants
|
65 Participants
|
|
Percent Reduction From Baseline in Worst Nighttime Pain
≥ 30% Reduction from BL
|
59 Participants
|
56 Participants
|
|
Percent Reduction From Baseline in Worst Nighttime Pain
≥ 50% Reduction from BL
|
36 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population
WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome)
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT
|
-12.5 score on a scale
Standard Error 1.07
|
-10.4 score on a scale
Standard Error 1.06
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population
WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome)
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in WOMAC Total Score at Week 4/EOT
|
-19.4 score on a scale
Standard Error 1.47
|
-17.1 score on a scale
Standard Error 1.46
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population
WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome)
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT
|
-1.6 score on a scale
Standard Error 0.14
|
-1.5 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 2Population: mITT Population
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)
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
WOMAC Stiffness score, Change from BL to Week 2
|
-1.4 score on a scale
Standard Error 0.13
|
-1.0 score on a scale
Standard Error 0.13
|
|
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
WOMAC Physical Function score, Change from BL to Week 2
|
-9.5 score on a scale
Standard Error 0.93
|
-8.0 score on a scale
Standard Error 0.91
|
|
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
WOMAC Total score, Change from BL to Week 2
|
-15.7 score on a scale
Standard Error 1.27
|
-13.2 score on a scale
Standard Error 1.25
|
|
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
WOMAC Pain score, Change from BL to Week 2
|
-4.7 score on a scale
Standard Error 0.29
|
-4.4 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Week 4 to Week 5Population: mITT Population
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)
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
WOMAC Total score, Change from Week 4/EOT to Week 5/FV2
|
3.5 score on a scale
Standard Error 0.89
|
2.7 score on a scale
Standard Error 0.89
|
|
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
WOMAC Pain score, Change from Week 4/EOT to Week 5/FV2
|
0.8 score on a scale
Standard Error 0.21
|
0.7 score on a scale
Standard Error 0.21
|
|
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
WOMAC Stiffness score, Change from Week 4/EOT to Week 5/FV2
|
0.3 score on a scale
Standard Error 0.10
|
0.3 score on a scale
Standard Error 0.10
|
|
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
WOMAC Physical Function score, Change from Week 4/EOT to Week 5/FV2
|
2.4 score on a scale
Standard Error 0.65
|
1.7 score on a scale
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Weeks 2, 4 and 5Population: mITT
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: * For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline * For baseline Grade = 1: a change in grade from 1 to 0 Worsened - defined as either of the following: * For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline * For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened
Outcome measures
| Measure |
G001 Topical Gel
n=102 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 2 · Improved
|
24 Participants
|
20 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 2 · No change
|
74 Participants
|
79 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 2 · Worsened
|
1 Participants
|
3 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 4 · Improved
|
38 Participants
|
28 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 4 · No change
|
64 Participants
|
72 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 4 · Worsened
|
0 Participants
|
4 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 5 · Improved
|
26 Participants
|
21 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 5 · No change
|
73 Participants
|
75 Participants
|
|
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of DA, Change from BL to Week 5 · Worsened
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4 and 5Population: mITT Population
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: * For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline * For baseline Grade = 1: a change in grade from 1 to 0 Worsened - defined as either of the following: * For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline * For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 2 · Improved
|
24 Participants
|
22 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 2 · No Change
|
74 Participants
|
77 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 2 · Worsened
|
1 Participants
|
3 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 4 · Improved
|
39 Participants
|
29 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 4 · No Change
|
63 Participants
|
72 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 4 · Worsened
|
1 Participants
|
3 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 5 · Improved
|
30 Participants
|
21 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 5 · No Change
|
67 Participants
|
78 Participants
|
|
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of DA, Change from BL to Week 5 · Worsened
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 2 and 4Population: mITT Population
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.
Outcome measures
| Measure |
G001 Topical Gel
n=102 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
PGA of Overall Treatment Benefit (OTB)
PGA of OTB at Week 2 · Good or Very Good
|
32 Participants
|
39 Participants
|
|
PGA of Overall Treatment Benefit (OTB)
PGA of OTB at Week 2 · Fair
|
49 Participants
|
47 Participants
|
|
PGA of Overall Treatment Benefit (OTB)
PGA of OTB at Week 2 · Poor or Very Poor
|
18 Participants
|
16 Participants
|
|
PGA of Overall Treatment Benefit (OTB)
PGA of OTB at Week 4 · Good or Very Good
|
50 Participants
|
46 Participants
|
|
PGA of Overall Treatment Benefit (OTB)
PGA of OTB at Week 4 · Fair
|
36 Participants
|
38 Participants
|
|
PGA of Overall Treatment Benefit (OTB)
PGA of OTB at Week 4 · Poor or Very Poor
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Weeks 2 and 4Population: mITT Population
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.
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
IGA of Overall Treatment Benefit (OTB)
IGA of OTB, Week 4 · Poor or Very Poor
|
16 Participants
|
19 Participants
|
|
IGA of Overall Treatment Benefit (OTB)
IGA of OTB, Week 2 · Very Good or Good
|
32 Participants
|
40 Participants
|
|
IGA of Overall Treatment Benefit (OTB)
IGA of OTB, Week 2 · Fair
|
47 Participants
|
47 Participants
|
|
IGA of Overall Treatment Benefit (OTB)
IGA of OTB, Week 2 · Poor or Very Poor
|
20 Participants
|
15 Participants
|
|
IGA of Overall Treatment Benefit (OTB)
IGA of OTB, Week 4 · Very Good or Good
|
52 Participants
|
46 Participants
|
|
IGA of Overall Treatment Benefit (OTB)
IGA of OTB, Week 4 · Fair
|
35 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: mITT Population
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.
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Rescue Medication Use
|
71.6 mg/day
Standard Deviation 66.65
|
94.6 mg/day
Standard Deviation 123.3
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: mITT Population
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.
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Number of Rescue Medication Doses
|
5.9 number of doses
Standard Deviation 6.03
|
7.9 number of doses
Standard Deviation 12.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: Safety Population
Number and percentage of participants with adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation
Outcome measures
| Measure |
G001 Topical Gel
n=105 Participants
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
|
Vehicle Topical Gel
n=105 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation
Any TEAE
|
36 Participants
|
28 Participants
|
|
Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation
Treatment-related TEAEs
|
5 Participants
|
4 Participants
|
|
Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation
Any SAE
|
0 Participants
|
1 Participants
|
|
Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation
Any TEAE leading to Discontinuation
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: Safety Population
Number and percentage of participants with application site AEs
Outcome measures
| Measure |
G001 Topical Gel
n=105 Participants
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
|
Vehicle Topical Gel
n=105 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Frequency and Severity of Application Site AEs
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 2, 4, and 6Population: Safety Population
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.
Outcome measures
| Measure |
G001 Topical Gel
n=103 Participants
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
|
Vehicle Topical Gel
n=104 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 2 · Numerical Total Score of 1
|
1 Participants
|
0 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 4/EOT · Numerical Total Score of 1
|
1 Participants
|
1 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 4/EOT · Numerical Total Score of ≥2
|
1 Participants
|
0 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 6 · Numerical Total Score of 0
|
101 Participants
|
101 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 6 · Numerical Total Score of 1
|
0 Participants
|
0 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 6 · Numerical Total Score of ≥2
|
0 Participants
|
0 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 2 · Numerical Total Score of 0
|
98 Participants
|
101 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 2 · Numerical Total Score of ≥2
|
1 Participants
|
1 Participants
|
|
Skin Irritation Test Scores (Berger/Bowman Scoring Scale)
Skin Irritation Total Score, Week 4/EOT · Numerical Total Score of 0
|
101 Participants
|
103 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksPopulation: Safety Population
Number and percentage of participants with clinically significant (CS) abnormal results in QT, QTc, QRS, or PR intervals at Week 4/EOT
Outcome measures
| Measure |
G001 Topical Gel
n=105 Participants
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
|
Vehicle Topical Gel
n=105 Participants
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
ECG Abnormalities in QT, QTc, QRS, or PR Intervals
CS QT Interval abnormality
|
0 Participants
|
0 Participants
|
|
ECG Abnormalities in QT, QTc, QRS, or PR Intervals
CS QTc Interval abnormality
|
0 Participants
|
0 Participants
|
|
ECG Abnormalities in QT, QTc, QRS, or PR Intervals
CS QRS Interval abnormality
|
0 Participants
|
0 Participants
|
|
ECG Abnormalities in QT, QTc, QRS, or PR Intervals
CS PR Interval abnormality
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksMean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksMean changes (descriptive) from baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksNumber and percentage of participants with clinically significant abnormal findings
Outcome measures
Outcome data not reported
Adverse Events
G001 Topical Gel
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle Topical Gel
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
G001 Topical Gel
n=105 participants at risk
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
|
Vehicle Topical Gel
n=105 participants at risk
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/105 • 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.
|
0.95%
1/105 • Number of events 1 • 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.
|
Other adverse events
| Measure |
G001 Topical Gel
n=105 participants at risk
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
|
Vehicle Topical Gel
n=105 participants at risk
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Vehicle: Vehicle Gel for topical administration
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.5%
10/105 • Number of events 14 • 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.
|
4.8%
5/105 • Number of events 11 • 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.
|
Additional Information
Deirdre O'Keefe, PhD, Head of IP and Portfolio Management
Buzzz Pharmaceuticals Limited
Phone: +447733104786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place