Trial Outcomes & Findings for To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion). (NCT NCT02596451)
NCT ID: NCT02596451
Last Updated: 2017-06-28
Results Overview
The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1164 participants
Primary outcome timeframe
Baseline and week 4
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Test
Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
|
Reference
Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
|
Placebo
Vehicle gel (Glenmark Pharmaceuticals Ltd)
|
|---|---|---|---|
|
Overall Study
STARTED
|
385
|
392
|
387
|
|
Overall Study
COMPLETED
|
381
|
374
|
373
|
|
Overall Study
NOT COMPLETED
|
4
|
18
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).
Baseline characteristics by cohort
| Measure |
Test
n=383 Participants
Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
|
Reference
n=382 Participants
Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
|
Placebo
n=378 Participants
Vehicle gel (Glenmark Pharmaceuticals Ltd)
|
Total
n=1143 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 10.68 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
734 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
409 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 4The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
Outcome measures
| Measure |
Test
n=309 Participants
Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
|
Reference
n=285 Participants
Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
|
|---|---|---|
|
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
|
5.8 units on a scale
Standard Deviation 3.96
|
5.9 units on a scale
Standard Deviation 3.94
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Reference
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test
n=383 participants at risk
Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
|
Reference
n=382 participants at risk
Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
|
Placebo
n=378 participants at risk
Vehicle gel (Glenmark Pharmaceuticals Ltd)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/383
|
0.26%
1/382 • Number of events 1
|
0.00%
0/378
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/383
|
0.26%
1/382 • Number of events 1
|
0.00%
0/378
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/383
|
0.26%
1/382 • Number of events 1
|
0.00%
0/378
|
|
Surgical and medical procedures
L Ankle Surgery Secondary To Trimalleolar Fracture
|
0.00%
0/383
|
0.26%
1/382 • Number of events 1
|
0.00%
0/378
|
|
Surgical and medical procedures
Right Ankle Surgery Due To Stair Fall
|
0.00%
0/383
|
0.00%
0/382
|
0.26%
1/378 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/383
|
0.00%
0/382
|
0.00%
0/378
|
Other adverse events
| Measure |
Test
n=383 participants at risk
Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd)
|
Reference
n=382 participants at risk
Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc)
|
Placebo
n=378 participants at risk
Vehicle gel (Glenmark Pharmaceuticals Ltd)
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
7.3%
28/383 • Number of events 38
|
6.8%
26/382 • Number of events 46
|
6.1%
23/378 • Number of events 36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER