CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Melatonin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04684199
NCT04684199N/ACompleted
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The Therapeutic Effect of Melatonin in Pediatric Patients With Functional Dyspepsia

Children's Mercy Hospital Kansas City·interventional·Posted Dec 24, 2020·Updated Dec 24, 2020

In Brief

A clinical study evaluating Melatonin and Placebo for Dyspepsia. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspepsia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 24, 2020
Enrollment StartAug 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.5 years ago

Interventions

Melatonindietary

Comparison between melatonin and placebo (2 weeks each) with active and placebo crossover during the study period of 34-36 days.

Placebodietary