Trial · NCT03172780

A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"

NCT03172780, Phase 3, Completed, Mylan Pharmaceuticals Private Limited; results first posted 2021-04-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee". Trials, record NCT03172780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03172780

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
NCT number: NCT03172780
Status: Completed
Phases: Phase 3
Enrollment: 1,220 participants, actual
Lead sponsor: Mylan Pharmaceuticals Private Limited
Conditions: Osteoarthritis, Knee
Interventions: Diclofenac sodium gel 1%, Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%, Placebo gel
First posted: 2017-06-01
Last updated: 2022-03-03
Results first posted: 2021-04-20

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change in the Total WOMAC Pain Subscale Score	From baseline to week 4	Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
Primary	Change From Baseline in WOMAC Pain Subscale Score	4 weeks	Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo. Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in the Total WOMAC Pain Subscale Score	From baseline to week 4	The PP Population was used for analysis of clinical equivalence between Mylan's Diclofenac gel and Voltaren gel. The primary outcome tested in this population was the equivalence of Mylan's Diclofenac sodium gel (1%) verses the Voltaren gel (1%) and thus only Diclofenac Sodium Gel and Voltaren Gel arms are present here. The placebo arm is presented for the superiority analysis.	score on a scale	MEAN
PRIMARY	Change From Baseline in WOMAC Pain Subscale Score	4 weeks	The mITT Population was used for analysis of superiority of Mylan's Diclofenac gel and Voltaren gel over placebo. The primary outcome tested in this population was the superiority of Mylan's Diclofenac sodium gel (1%) and the Voltaren gel (1%) over placebo and thus all the three arms are presented here.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change in the Total WOMAC Pain Subscale Score	Diclofenac Sodium Gel	-4.3	Standard Deviation 2.64	score on a scale
Mean Change in the Total WOMAC Pain Subscale Score	Voltaren® Gel	-4.6	Standard Deviation 2.64	score on a scale
Change From Baseline in WOMAC Pain Subscale Score	Diclofenac Sodium Gel	-4.2	Standard Deviation 2.84	score on a scale
Change From Baseline in WOMAC Pain Subscale Score	Voltaren® Gel	-4.4	Standard Deviation 2.74	score on a scale
Change From Baseline in WOMAC Pain Subscale Score	Placebo Gel	-3.2	Standard Deviation 3.46	score on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Diclofenac Sodium Gel	406
Overall Study	STARTED	Voltaren® Gel	409
Overall Study	STARTED	Placebo Gel	405
Overall Study	COMPLETED	Diclofenac Sodium Gel	388
Overall Study	COMPLETED	Voltaren® Gel	389
Overall Study	COMPLETED	Placebo Gel	389
Overall Study	NOT COMPLETED	Diclofenac Sodium Gel	18
Overall Study	NOT COMPLETED	Voltaren® Gel	20
Overall Study	NOT COMPLETED	Placebo Gel	16

Source ClinicalTrials.gov

Adverse events12

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	Diclofenac Sodium Gel	4	398	5
other	Headache	Nervous system disorders	Voltaren® Gel	9	405	12
other	Headache	Nervous system disorders	Placebo Gel	11	400	14
other	Pyrexia	General disorders	Diclofenac Sodium Gel	6	398	6
other	Pyrexia	General disorders	Voltaren® Gel	6	405	9
other	Pyrexia	General disorders	Placebo Gel	9	400	11
other	Eosinophilia	Blood and lymphatic system disorders	Diclofenac Sodium Gel	1	398	1
other	Eosinophilia	Blood and lymphatic system disorders	Voltaren® Gel	4	405	4
other	Eosinophilia	Blood and lymphatic system disorders	Placebo Gel	0	400	0
serious	Completed Suicide	Psychiatric disorders	Diclofenac Sodium Gel	0	398	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Diclofenac Sodium Gel	0	398
Total, all-cause mortality	Voltaren® Gel	1	405
Total, all-cause mortality	Placebo Gel	0	400
Total, other adverse events	Diclofenac Sodium Gel	11	398
Total, other adverse events	Voltaren® Gel	19	405
Total, other adverse events	Placebo Gel	20	400
Total, serious adverse events	Diclofenac Sodium Gel	0	398
Total, serious adverse events	Voltaren® Gel	1	405
Total, serious adverse events	Placebo Gel	0	400

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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GET https://conductscience.org/api/trials/v1/NCT03172780/registered

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