Trial · NCT02121002
Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
NCT02121002, Phase 3, Completed, Amneal Pharmaceuticals, LLC; results first posted 2021-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee. Trials, record NCT02121002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02121002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
- NCT number
- NCT02121002
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,176 participants, actual
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Conditions
- Osteoarthritis
- Interventions
- Diclofenac Sodium Topical Gel, 1%, Voltaren Topical Gel, 1%, Vehicle Diclofenac Sodium Topical Gel
- First posted
- 2014-04-23
- Last updated
- 2021-06-16
- Results first posted
- 2021-06-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 4 Weeks in WOMAC Pain Score | Baseline and Week 4 | 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 |
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 | Change From Baseline to 4 Weeks in WOMAC Pain Score | Baseline and Week 4 | 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 | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 4 Weeks in WOMAC Pain Score | Diclofenac Sodium Topical Gel, 1% | 2.2332 | Standard Error 0.1160 | score on a scale | |
| Change From Baseline to 4 Weeks in WOMAC Pain Score | Voltaren Topical Gel, 1% | 2.0287 | Standard Error 0.1157 | score on a scale | |
| Change From Baseline to 4 Weeks in WOMAC Pain Score | Vehicle Diclofenac Sodium Topical Gel | -0.6387 | Standard Error 0.1172 | score 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 | Diclofenac Sodium Topical Gel, 1% | 392 | |
| Overall Study | STARTED | Voltaren Topical Gel, 1% | 393 | |
| Overall Study | STARTED | Vehicle Diclofenac Sodium Topical Gel | 391 | |
| Overall Study | COMPLETED | Diclofenac Sodium Topical Gel, 1% | 385 | |
| Overall Study | COMPLETED | Voltaren Topical Gel, 1% | 389 | |
| Overall Study | COMPLETED | Vehicle Diclofenac Sodium Topical Gel | 381 | |
| Overall Study | NOT COMPLETED | Diclofenac Sodium Topical Gel, 1% | 7 | |
| Overall Study | NOT COMPLETED | Voltaren Topical Gel, 1% | 4 | |
| Overall Study | NOT COMPLETED | Vehicle Diclofenac Sodium Topical Gel | 10 |
Source ClinicalTrials.gov
Adverse events18
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 | Gastrooesophageal reflux disease | Gastrointestinal disorders | Diclofenac Sodium Topical Gel, 1% | 0 | 391 | 0 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Voltaren Topical Gel, 1% | 0 | 393 | 0 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Vehicle Diclofenac Sodium Topical Gel | 1 | 391 | 1 |
| other | Oedema, | General disorders | Diclofenac Sodium Topical Gel, 1% | 1 | 391 | 1 |
| other | Oedema, | General disorders | Voltaren Topical Gel, 1% | 0 | 393 | 0 |
| other | Oedema, | General disorders | Vehicle Diclofenac Sodium Topical Gel | 0 | 391 | 0 |
| other | Nasopharyngitis Cough | Infections and infestations | Diclofenac Sodium Topical Gel, 1% | 0 | 391 | 0 |
| other | Nasopharyngitis Cough | Infections and infestations | Voltaren Topical Gel, 1% | 0 | 393 | 0 |
| other | Nasopharyngitis Cough | Infections and infestations | Vehicle Diclofenac Sodium Topical Gel | 1 | 391 | 1 |
| other | Pyrexia | General disorders | Diclofenac Sodium Topical Gel, 1% | 0 | 391 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diclofenac Sodium Topical Gel, 1% | 0 | 391 |
| Total, all-cause mortality | Voltaren Topical Gel, 1% | 0 | 393 |
| Total, all-cause mortality | Vehicle Diclofenac Sodium Topical Gel | 0 | 391 |
| Total, other adverse events | Diclofenac Sodium Topical Gel, 1% | 2 | 391 |
| Total, other adverse events | Voltaren Topical Gel, 1% | 2 | 393 |
| Total, other adverse events | Vehicle Diclofenac Sodium Topical Gel | 3 | 391 |
| Total, serious adverse events | Diclofenac Sodium Topical Gel, 1% | 0 | 391 |
| Total, serious adverse events | Voltaren Topical Gel, 1% | 0 | 393 |
| Total, serious adverse events | Vehicle Diclofenac Sodium Topical Gel | 0 | 391 |
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/NCT02121002
GET https://conductscience.org/api/trials/v1/NCT02121002/registered