At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 876 enrolled
Drug / intervention
Econazole Nitrate Cream, 1% +1 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.
Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Econazole Nitrate Cream, 1% (Renaissance Pharma, Inc.) to Econazole Nitrate Cream, 1% (Perrigo New York Inc.) in Tinea Pedis
In Brief
A Phase 3 clinical trial evaluating Econazole Nitrate Cream, 1% and Placebo for Tinea Pedis. Completed, enrolled 876 participants.
Detailed Summary
To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis. To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis. To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinea Pedis
Countries--
CollaboratorsDPT Laboratories, Ltd.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
Primary CompletionNov 2016
First PostedApr 2017
TodayJul 2026
First PostedApr 26, 2017
Enrollment StartMar 15, 2016
Primary CompletionNov 17, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.2 years ago
Interventions
Econazole Nitrate Cream, 1%drug
Placebodrug