Trials / Completed
CompletedNCT03196973
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 493 (actual)
- Sponsor
- Salvat · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DF289 plus DF277 | 1 vial into the affected ear twice daily for 7 days |
| DRUG | DF289 | 1 vial into the affected ear twice daily for 7 days |
| DRUG | DF277 | 1 vial into the affected ear twice daily for 7 days |
Timeline
- Start date
- 2017-07-22
- Primary completion
- 2018-08-31
- Completion
- 2018-09-14
- First posted
- 2017-06-23
- Last updated
- 2021-04-09
- Results posted
- 2021-04-09
Locations
1 site across 1 country: Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03196973. Inclusion in this directory is not an endorsement.