Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Phase 1

Withdrawn

• Conditions: Functional Dyspepsia; Functional Abdominal Pain; Irritable Bowel Syndrome
• Interventions: Other: Sugar pill; Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone

• Registration Number: NCT01269671
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

IND application was submitted to FDA on November 17th.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2012-01
• Study Completion: 2012-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Sugar pill	-
Melatonin, Peppermint Oil, Simethicone	Melatonin, Peppermint Oil (mentharil), and Simethicone	-

Primary Outcome Measures

Name	Time	Method
Pain Reduction	8 weeks	To evaluate the efficacy of the treatment combination of Melatonin, Peppermint Oil, and Simethicone in releiving the symptoms of pain in Irritable Bowel Syndrome, Functional Abdominal Pain, and Functional Dyspepsia compared to treatment outcomes to placebo.
Quality of Life	8 weeks	To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
Anxiety Affects	8 weeks	To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States