Trials / Completed
CompletedNCT03116737
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Lachlan Pharma Holdings · Industry
- Sex
- All
- Age
- 5 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Benzocaine Otic Solution | |
| DRUG | Placebo |
Timeline
- Start date
- 2017-01-03
- Primary completion
- 2017-07-21
- Completion
- 2017-07-21
- First posted
- 2017-04-17
- Last updated
- 2017-10-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03116737. Inclusion in this directory is not an endorsement.