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NCT00127686 · ClinicalTrials.gov registry record · Phase 1
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
A Phase 1 study of Respiratory Tract Infections and Cough, sponsored by Penn State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT00127686: Completed Phase 1 study of Respiratory Tract Infections and Cough, sponsored by Penn State University.
NCT00127686 is a Phase 1 study of Respiratory Tract Infections and Cough that has completed, run by Penn State University. The registered enrollment target is 105 participants, below the 2,767-participant average among 15 other Respiratory Tract Infections trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00127686, a Phase 1 study of Respiratory Tract Infections and Cough, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
Cough is the most common reason for an acute care doctor's visit in the United States. Cough can affect sleep for both coughing children and their parents. The American Academy of Pediatrics does not endorse the use of dextromethorphan (DM), the most common over-the-counter (OTC) cough medication because of a lack of efficacy data and some potential for toxicity, particularly when taken in excess. In fact, DM has previously been shown to be no better than a placebo for cough in children. Therefore, alternative, therapeutic agents are needed. Honey anecdotally provides relief for symptoms due to upper respiratory tract infection (URI). This study seeks to use a survey to evaluate whether a single dose of honey and/or DM is better than no treatment at all for controlling nocturnal cough in children with URI and the effect of the treatments on sleep quality for coughing children and their parents. A single dose of honey or DM will be superior to no treatment for control of nocturnal cough due to upper URI as rated by both parents and children and will improve the sleep quality for those children and parents. Compared to DM, honey will be superior for controlling nocturnal cough due to upper URI (also based on child and parental report).
Conditions Studied
Interventions
- DRUG Dextromethorphan
- DRUG Buckwheat Honey
Study Locations (1)
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2005-09 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
What the finished NCT00127686 record still lists
NCT00127686 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 2,767-participant average among 15 other Respiratory Tract Infections trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Respiratory Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which Dextromethorphan is the first listed.
NCT00127686 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00127686 about?
NCT00127686 is a clinical study titled "Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep". Cough is the most common reason for an acute care doctor's visit in the United States. Cough can affect sleep for both coughing children and their parents. The American Academy of Pediatrics does not endorse the use of dextromethorphan (DM), the most common over-the-counter (OTC) cough medication be...
What is the current status of trial NCT00127686?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2005-09. Estimated completion is 2006-12.
What conditions does trial NCT00127686 study?
This clinical trial studies the following conditions: Respiratory Tract Infections, Cough.
What interventions are being tested in trial NCT00127686?
The interventions under investigation include: Dextromethorphan (DRUG), Buckwheat Honey (DRUG).
Who is sponsoring clinical trial NCT00127686?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00127686 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00127686's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Tract Infections 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.
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