Trial Outcomes & Findings for Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee (NCT NCT02121002)
NCT ID: NCT02121002
Last Updated: 2021-06-16
Results Overview
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1176 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2021-06-16
Participant Flow
Participant milestones
| Measure |
Diclofenac Sodium Topical Gel, 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%: Opaque, white gel
|
Voltaren Topical Gel, 1%
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren Topical Gel, 1%: Opaque, white gel
|
Vehicle Diclofenac Sodium Topical Gel
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
392
|
393
|
391
|
|
Overall Study
COMPLETED
|
385
|
389
|
381
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
10
|
Reasons for withdrawal
| Measure |
Diclofenac Sodium Topical Gel, 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%: Opaque, white gel
|
Voltaren Topical Gel, 1%
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren Topical Gel, 1%: Opaque, white gel
|
Vehicle Diclofenac Sodium Topical Gel
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
4
|
|
Overall Study
Protocol Violation
|
1
|
2
|
4
|
|
Overall Study
Concomitant therapy
|
0
|
1
|
1
|
|
Overall Study
Others
|
1
|
0
|
1
|
Baseline Characteristics
Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Diclofenac Sodium Topical Gel, 1%
n=391 Participants
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%: Opaque, white gel
|
Voltaren Topical Gel, 1%
n=393 Participants
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren Topical Gel, 1%: Opaque, white gel
|
Vehicle Diclofenac Sodium Topical Gel
n=391 Participants
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel
|
Total
n=1175 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<= 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
between 18 and 65 years
|
357 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
1062 Participants
n=4 Participants
|
|
Age, Customized
>=65year
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
255 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
753 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Across study groups, the per protocol (PP) population included 1147 subjects (97.53%) and the modified intention-to-treat (mITT) population included 1166 subjects (99.15%). For various reasons, 10 subjects were excluded from mITT population while 29 subjects were excluded from PP population out of 1176 subjects randomized in the study
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
Outcome measures
| Measure |
Diclofenac Sodium Topical Gel, 1%
n=391 Participants
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%: Opaque, white gel
|
Voltaren Topical Gel, 1%
n=393 Participants
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren Topical Gel, 1%: Opaque, white gel
|
Vehicle Diclofenac Sodium Topical Gel
n=391 Participants
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel
|
|---|---|---|---|
|
Change From Baseline to 4 Weeks in WOMAC Pain Score
|
2.2332 score on a scale
Standard Error 0.1160
|
2.0287 score on a scale
Standard Error 0.1157
|
-0.6387 score on a scale
Standard Error 0.1172
|
Adverse Events
Diclofenac Sodium Topical Gel, 1%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Voltaren Topical Gel, 1%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vehicle Diclofenac Sodium Topical Gel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diclofenac Sodium Topical Gel, 1%
n=391 participants at risk
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%: Opaque, white gel
|
Voltaren Topical Gel, 1%
n=393 participants at risk
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren Topical Gel, 1%: Opaque, white gel
|
Vehicle Diclofenac Sodium Topical Gel
n=391 participants at risk
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/393 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.26%
1/391 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
|
General disorders
Oedema,
|
0.26%
1/391 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/393 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
|
Infections and infestations
Nasopharyngitis Cough
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/393 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.26%
1/391 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
|
General disorders
Pyrexia
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.25%
1/393 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.26%
1/391 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
|
Skin and subcutaneous tissue disorders
Pruritus and Rash Pruritic
|
0.26%
1/391 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/393 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
|
Nervous system disorders
Headache
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.25%
1/393 • Number of events 1 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
0.00%
0/391 • The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place