Status:

COMPLETED

Melatonin in Pediatric FD Population

Lead Sponsor:

Children's Mercy Hospital Kansas City

Conditions:

Dyspepsia

Eligibility:

All Genders

8-17 years

Phase:

NA

Brief 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). Hypothe...

Detailed Description

Recurrent abdominal pain is present in a significant proportion of the pediatric population at large. Often times, no clear organic cause for pain will be found, and these children are diagnosed with ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT04684199

Start Date

August 1 2014

End Date

April 1 2015

Last Update

December 24 2020

Active Locations (1)

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Children's Mercy

Kansas City, Missouri, United States, 64108