At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 934 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 Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
In Brief
A Phase 3 clinical trial evaluating Diclofenac Sodium Gel 1%, Voltaren Gel, and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 934 participants across 51 sites in 6 countries.
Detailed Summary
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesEstonia, Latvia, Lithuania, Poland, Romania, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
Primary CompletionApr 2016
Study CompletionJun 2016
First PostedSep 2016
TodayJul 2026
First PostedSep 23, 2016
Enrollment StartJun 1, 2015
Primary CompletionApr 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.8 years ago
Interventions
Diclofenac Sodium Gel 1%drug
Voltaren Geldrug
Placebodrug