Trial · NCT02596451
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).
NCT02596451, Phase 3, Completed, Glenmark Pharmaceuticals Ltd. India; results first posted 2017-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT02596451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02596451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT02596451
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,164 participants, actual
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Conditions
- Osteoarthritis
- Interventions
- Diclofenac Sodium gel, 1%, Voltaren® Gel, Placebo
- First posted
- 2015-11-04
- Last updated
- 2017-06-28
- Results first posted
- 2017-06-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | Baseline and week 4 | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | Baseline and week 4 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | Test | 5.8 | Standard Deviation 3.96 | units on a scale | |
| Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | Reference | 5.9 | Standard Deviation 3.94 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test | 385 | |
| Overall Study | STARTED | Reference | 392 | |
| Overall Study | STARTED | Placebo | 387 | |
| Overall Study | COMPLETED | Test | 381 | |
| Overall Study | COMPLETED | Reference | 374 | |
| Overall Study | COMPLETED | Placebo | 373 | |
| Overall Study | NOT COMPLETED | Test | 4 | |
| Overall Study | NOT COMPLETED | Reference | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Test | 28 | 383 | 38 |
| other | Headache | Nervous system disorders | Reference | 26 | 382 | 46 |
| other | Headache | Nervous system disorders | Placebo | 23 | 378 | 36 |
| serious | Rib Fracture | Injury, poisoning and procedural complications | Test | 0 | 383 | 0 |
| serious | Rib Fracture | Injury, poisoning and procedural complications | Reference | 1 | 382 | 1 |
| serious | Rib Fracture | Injury, poisoning and procedural complications | Placebo | 0 | 378 | 0 |
| serious | Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Test | 0 | 383 | 0 |
| serious | Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Reference | 1 | 382 | 1 |
| serious | Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 378 | 0 |
| serious | Nausea | Gastrointestinal disorders | Test | 0 | 383 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test | ||
| Total, all-cause mortality | Reference | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Test | 28 | 383 |
| Total, other adverse events | Reference | 26 | 382 |
| Total, other adverse events | Placebo | 23 | 378 |
| Total, serious adverse events | Test | 0 | 383 |
| Total, serious adverse events | Reference | 2 | 382 |
| Total, serious adverse events | Placebo | 1 | 378 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02596451
GET https://conductscience.org/api/trials/v1/NCT02596451/events?page=2