CompletedNot Applicable

Melatonin in Pediatric FD Population

United States14 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range8 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Grade of clinical response to Melatonin in children with functional dyspepsia

Timeframe: 35 days

Trial details

NCT IDNCT04684199

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

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