Melatonin in Pediatric FD Population

Completed · Not applicable · Has a placebo group

Conditions studied: Dyspepsia

In brief

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.

Key facts

Study ID

NCT04684199

Run by

Children's Mercy Hospital Kansas City

People needed

14

Starts

2014-08-01

Expected to finish

2015-04-01

Last updated by the study team

2020-12-24

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients seen in the GI clinic with a diagnosis of functional dyspepsia as defined by Rome III criteria.
• Persistent pain despite acid suppression at therapeutic doses for at least 4 weeks
• Patients ages 8-17 years, inclusive.

You may not qualify if…

• Patients currently using melatonin.
• Patients who have previously had endoscopy.
• Initiation of a treatment plan that includes one or more of the following medications in the last 4 weeks
• Opiates
• Tramadol
• Gabapentin
• Benzodiazepines

Where it is running

• Children's Mercy — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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