At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,176 enrolled
Drug / intervention
Diclofenac Sodium Topical Gel, 1% +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee
In Brief
A Phase 3 clinical trial evaluating Diclofenac Sodium Topical Gel, 1%, Voltaren Topical Gel, 1%, and 1 other intervention for Osteoarthritis. Completed, enrolled 1,176 participants across 22 sites.
Detailed Summary
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesIndia
CollaboratorsSristek Clinical Research Solutions Limited
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionOct 2014
Study CompletionDec 2014
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartApr 1, 2014
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.2 years ago
Interventions
Diclofenac Sodium Topical Gel, 1%drug
Opaque, white gel
Voltaren Topical Gel, 1%drug
Opaque, white gel
Vehicle Diclofenac Sodium Topical Geldrug
Opaque, white gel