Trial · NCT02913521
Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%
NCT02913521, Phase 3, Completed, Akorn, Inc.; results first posted 2021-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%. Trials, record NCT02913521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02913521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%
- NCT number
- NCT02913521
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 934 participants, actual
- Lead sponsor
- Akorn, Inc.
- Conditions
- Osteoarthritis, Knee
- Interventions
- Diclofenac Sodium Gel 1%, Voltaren Gel, Placebo
- First posted
- 2016-09-23
- Last updated
- 2021-02-26
- Results first posted
- 2021-02-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. | 8 weeks | WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20). |
| Secondary | An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score. | 8 weeks | WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20). |
| Secondary | Incidences of Treatment Emergent Adverse Events | 8 weeks | |
| Secondary | Incidences of Abnormal Vital Signs | 8 weeks | |
| Secondary | Clinically Significant Changes From Baseline in Physical Examination Results | 8 weeks |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. | 8 weeks | units on a scale | MEAN | |
| SECONDARY | An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score. | 8 weeks | mITT | units on a scale | MEAN |
| SECONDARY | Incidences of Treatment Emergent Adverse Events | 8 weeks | |||
| SECONDARY | Incidences of Abnormal Vital Signs | 8 weeks | |||
| SECONDARY | Clinically Significant Changes From Baseline in Physical Examination Results | 8 weeks |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. | Diclofenac Sodium Gel 1% | 6.8 | Standard Deviation 2.1 | units on a scale | |
| Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. | Voltaren Gel | 6.7 | Standard Deviation 2.3 | units on a scale | |
| Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference. | Placebo | 5.9 | Standard Deviation 2.4 | units on a scale | |
| An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score. | Diclofenac Sodium Gel 1% | 6.8 | Standard Deviation 1.9 | units on a scale | |
| An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score. | Voltaren Gel | 6.6 | Standard Deviation 2.0 | units on a scale | |
| An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score. | Placebo | 5.9 | Standard Deviation 2.1 | 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 | Diclofenac Sodium Gel 1% | 316 | |
| Overall Study | STARTED | Voltaren Gel | 312 | |
| Overall Study | STARTED | Placebo | 306 | |
| Overall Study | COMPLETED | Diclofenac Sodium Gel 1% | 263 | |
| Overall Study | COMPLETED | Voltaren Gel | 262 | |
| Overall Study | COMPLETED | Placebo | 261 | |
| Overall Study | NOT COMPLETED | Diclofenac Sodium Gel 1% | 53 | |
| Overall Study | NOT COMPLETED | Voltaren Gel | 50 | |
| Overall Study | NOT COMPLETED | Placebo | 45 |
Source ClinicalTrials.gov
Adverse events6
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 | application site reaction | Skin and subcutaneous tissue disorders | Diclofenac Sodium Gel 1% | 6 | 316 | 316 |
| other | application site reaction | Skin and subcutaneous tissue disorders | Voltaren Gel | 4 | 312 | 312 |
| other | application site reaction | Skin and subcutaneous tissue disorders | Placebo | 3 | 306 | 306 |
| other | General disorders, muscle/skeletal, and nervous system | Investigations | Diclofenac Sodium Gel 1% | 24 | 316 | 316 |
| other | General disorders, muscle/skeletal, and nervous system | Investigations | Voltaren Gel | 20 | 312 | 312 |
| other | General disorders, muscle/skeletal, and nervous system | Investigations | Placebo | 17 | 306 | 306 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diclofenac Sodium Gel 1% | 0 | 316 |
| Total, all-cause mortality | Voltaren Gel | 0 | 312 |
| Total, all-cause mortality | Placebo | 0 | 306 |
| Total, other adverse events | Diclofenac Sodium Gel 1% | 30 | 316 |
| Total, other adverse events | Voltaren Gel | 24 | 312 |
| Total, other adverse events | Placebo | 20 | 306 |
| Total, serious adverse events | Diclofenac Sodium Gel 1% | 0 | 316 |
| Total, serious adverse events | Voltaren Gel | 0 | 312 |
| Total, serious adverse events | Placebo | 0 | 306 |
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/NCT02913521
GET https://conductscience.org/api/trials/v1/NCT02913521/registered