At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,164 enrolled
Drug / intervention
Diclofenac Sodium 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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee
In Brief
A Phase 3 clinical trial evaluating Diclofenac Sodium gel, 1%, Voltaren® Gel, and 1 other intervention for Osteoarthritis. Completed, enrolled 1,164 participants across 44 sites.
Detailed Summary
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedNov 2015
Primary CompletionMar 2016
TodayJul 2026
First PostedNov 4, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.7 years ago
Interventions
Diclofenac Sodium gel, 1%drug
Voltaren® Geldrug
Placebodrug