Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Otitis Media and Acute Otitis Media, sponsored by Deborah Gentile.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00189462 record still lists
NCT00189462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 4,337-participant average among 14 other Otitis Media trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Otitis Media
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00189462's enrollment target sits among peer trials
99 10th of 14 higher than 5 of 14 other Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Otitis Media 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
-
Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
RECRUITING · Phase 4
-
Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
RECRUITING
-
In-Office Clinical Study of the Solo+ TTD
RECRUITING · NA
-
Coherent Optical Detection of Middle Ear Disease
RECRUITING · NA
-
Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
ACTIVE NOT RECRUITING · NA
-
Diagnostic Utility of Otosight Middle Ear Scope
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03965234 · 99 participants · Phase 1
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
- NCT04022616 · 99 participants
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
- NCT04042844 · 99 participants · Phase 2
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
- NCT04143724 · 99 participants · Phase 2
Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia