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NCT00189462 · ClinicalTrials.gov registry record · Phase 4
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
A Phase 4 study of Otitis Media and Acute Otitis Media, sponsored by Deborah Gentile.
- Completed
- Registry status
- Phase 4
- Development phase
- 99
- Enrollment target
- 2
- Study locations
NCT00189462 is a Phase 4 study of Otitis Media and Acute Otitis Media that has completed, run by Deborah Gentile. The registered enrollment target is 99 participants, below the 4,337-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00189462, a Phase 4 study of Otitis Media and Acute Otitis Media, has completed, sponsored by Deborah Gentile.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 99 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Montelukast
Study Locations (2)
Pennsylvania
- Bellevue Pediatric Associates - Bellevue
- Allegheny General Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2004-03 |
| Est. Completion | 2005-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00189462
The ClinicalTrials.gov registry entry for NCT00189462 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,337-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower). The listed sponsor is Deborah Gentile, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Otitis Media appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00189462 reports 2 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00189462 about?
NCT00189462 is a clinical study titled "A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children". The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
What is the current status of trial NCT00189462?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 99 participants. The study started on 2004-03. Estimated completion is 2005-12.
What conditions does trial NCT00189462 study?
This clinical trial studies the following conditions: Otitis Media, Acute Otitis Media, Ear Infection.
What interventions are being tested in trial NCT00189462?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG).
Who is sponsoring clinical trial NCT00189462?
This trial is sponsored by Deborah Gentile, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00189462 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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