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NCT04684199 · ClinicalTrials.gov registry record · NA
Melatonin in Pediatric FD Population
A NA study of Dyspepsia, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04684199: Completed NA study of Dyspepsia, sponsored by Children's Mercy Hospital Kansas City.
NCT04684199 is a NA study of Dyspepsia that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 14 participants, below the 76-participant average among 11 other Dyspepsia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04684199, a NA study of Dyspepsia, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
There are two specific aims in this study. Specific Aim 1: Determine if melatonin results in a higher grade of clinical response than does placebo in children with functional dyspepsia (FD). Hypothesis: treatment of FD with melatonin will result in a higher grade of clinical response than will treatment with a placebo. Specific Aim 2: Evaluate the relationship between changes in sleep and improvement in pain in pediatric patients with functional dyspepsia receiving melatonin. Hypothesis: There will be no association between improvement in pain and improvement in sleep in children with functional dyspepsia receiving melatonin.
Primary Outcome
The overall positive response rate (grade 3-5) will be compared between melatonin and placebo by the McNemar test.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Melatonin
Study Locations (1)
Missouri
- Children's Mercy - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT04684199 record still lists
NCT04684199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 76-participant average among 11 other Dyspepsia trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Dyspepsia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04684199 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04684199 about?
NCT04684199 is a clinical study titled "Melatonin in Pediatric FD Population". There are two specific aims in this study. Specific Aim 1: Determine if melatonin results in a higher grade of clinical response than does placebo in children with functional dyspepsia (FD). Hypothesis: treatment of FD with melatonin will result in a higher grade of clinical response than will tre...
What is the current status of trial NCT04684199?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2014-08. Estimated completion is 2015-04.
What conditions does trial NCT04684199 study?
This clinical trial studies the following conditions: Dyspepsia.
What interventions are being tested in trial NCT04684199?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04684199?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04684199 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dyspepsia
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 NCT04684199's enrollment target sits among peer trials
14 12th of 11 the lowest of 11 other Dyspepsia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dyspepsia 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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