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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1
Children's Mercy
Kansas City, Missouri, United States, 64108