Trials / Completed
CompletedNCT03129321
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 876 (actual)
- Sponsor
- Mylan Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Econazole Nitrate Cream, 1% | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-03-15
- Primary completion
- 2016-11-17
- Completion
- 2016-11-17
- First posted
- 2017-04-26
- Last updated
- 2022-03-07
- Results posted
- 2018-08-02
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03129321. Inclusion in this directory is not an endorsement.