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NCT01044030 · ClinicalTrials.gov registry record · Phase 3
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
A Phase 3 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT01044030 is a Phase 3 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 326 participants.
The verdict
NCT01044030, a Phase 3 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.
Interventions
- DRUG Placebo
- DRUG Xylitol syrup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01044030
The ClinicalTrials.gov registry entry for NCT01044030 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01044030 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01044030 about?
NCT01044030 is a clinical study titled "Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children". The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children...
What is the current status of trial NCT01044030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2010-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01044030?
The interventions under investigation include: Placebo (DRUG), Xylitol syrup (DRUG).
Who is sponsoring clinical trial NCT01044030?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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