drugset / Trial / NCT00980876
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Phase 3
Completed
224 enrolled
Farmoquimica S.A.
Pharmagenix Projetos em Medicina Farmacêutica Ltda. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.
Timeline
- Start
- 2012-04
- Primary completion
- 2015-01
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciprofloxacin | Small molecule | 2 mg/ml | Other |
| Subject | Hydrocortisone | Other / unclassified | 10 mg/ml | Other |