Overview

Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Status:
Withdrawn

Trial end date:
2012-04-01

Target enrollment:
0

Participant gender:
All

Summary

IND application was submitted to FDA on November 17th.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Medical College of Wisconsin

Treatments:

Melatonin
Peppermint oil
Simethicone

Criteria

Inclusion Criteria: To participate in this study, the child/teen must be a patient of the
FAP Clinic/GI Clinic in the Division of Gastroenterology at the Children's Hospital of
Wisconsin, and have a parent or legal guardian who is willing to participate. Children aged
8-18 years will be eligible for inclusion in the study.

Exclusion Criteria: Children or parents who are non-English speaking, or parents and/or
children with cognitive delay that precludes comprehension and completion of questionnaires
will be excluded from participating in this registry.