Trials / Terminated
TerminatedNCT01908803
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.
Detailed description
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AL-60371/AL-817 otic suspension | |
| DRUG | Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension | CIPRODEX® |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2013-07-26
- Last updated
- 2017-12-06
- Results posted
- 2015-09-24
Source: ClinicalTrials.gov record NCT01908803. Inclusion in this directory is not an endorsement.