A Phase 3 interventional study of Diclofenac Sodium gel, 1% and Voltaren® Gel in Osteoarthritis, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 44 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 3, Interventional, and Treatment
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 1,164 is above the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Glenmark Pharmaceuticals Ltd. India is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
apply gel to the target knee
Drug: Diclofenac Sodium gel, 1%
apply gel to the target knee
Drug: Voltaren® Gel
apply gel to the target knee
Drug: Placebo
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
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.
Time frame: Baseline and week 4
| Milestone | Test | Reference | Placebo |
|---|---|---|---|
| Started | 385 | 392 | 387 |
| Completed | 381 | 374 | 373 |
| Not completed | 4 | 18 | 14 |
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.
| units on a scale | Test | Reference |
|---|---|---|
| Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | 5.8 ± 3.96 | 5.9 ± 3.94 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | — | 0/383 (0%) | 28/383 (7.3%) |
| Reference | — | 2/382 (0.5%) | 26/382 (6.8%) |
| Placebo | — | 1/378 (0.3%) | 23/378 (6.1%) |
| Event | Test | Reference | Placebo |
|---|---|---|---|
| Right Ankle Surgery Due To Stair FallSurgical and medical procedures | 0/383 | 0/382 | 1/378 |
| Rib FractureInjury, poisoning and procedural complications | 0/383 | 1/382 | 0/378 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 0/383 | 1/382 | 0/378 |
| NauseaGastrointestinal disorders | 0/383 | 1/382 | 0/378 |
| L Ankle Surgery Secondary To Trimalleolar FractureSurgical and medical procedures | 0/383 | 1/382 | 0/378 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/383 | 0/382 | 0/378 |
| Event | Test | Reference | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 28/383 | 26/382 | 23/378 |
A total of 1164 subjects were randomized in the study; however there were 21 subjects excluded from the safety population randomized who did not received dose. (Test=2, Reference=10, Placebo=9). Therefore the subject numbers are not consistent with any of the rows in the Participant Flow module.
| Age, Continuous(years) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Mean | 56.2 ± 10.36 | 56.5 ± 10.68 | 56.7 ± 10.52 | 56.4 ± 10.51 |
| Sex: Female, Male(Participants) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Female | 249 | 237 | 248 | 734 |
| Male | 134 | 145 | 130 | 409 |
The record gives a start of Aug 2015, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 1 year 3 months after primary completion.
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diclofenac Sodium Gel
Glenmark Pharmaceuticals Ltd. India