Trials / Completed
CompletedNCT01244581
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- University of Oulu · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amoxicillin-clavulanate | Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days |
| DRUG | Placebo | Placebo mixture in two daily doses for 7 days |
Timeline
- Start date
- 1999-09-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2010-11-19
- Last updated
- 2012-06-20
Locations
2 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT01244581. Inclusion in this directory is not an endorsement.