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NCT00377260 · ClinicalTrials.gov registry record · Phase 4
Acute Otitis Media (AOM) Therapy Trial in Young Children
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 291
- Enrollment target
NCT00377260: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT00377260 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 291 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377260, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 291 participants
- Enrollment target
Study Summary
The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.
Primary Outcome
Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible s
Interventions
- DRUG Placebo
- DRUG amoxicillin-clavulanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00377260 record still lists
NCT00377260 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00377260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00377260 about?
NCT00377260 is a clinical study titled "Acute Otitis Media (AOM) Therapy Trial in Young Children". The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children...
What is the current status of trial NCT00377260?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 291 participants. The study started on 2006-11. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00377260?
The interventions under investigation include: Placebo (DRUG), amoxicillin-clavulanate (DRUG).
Who is sponsoring clinical trial NCT00377260?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00377260's enrollment target sits among peer trials
291 297th of 2000 higher than 1,704 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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