Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain (FAP)

Medical College of Wisconsin

Status and phase: Withdrawn; Phase 1

Conditions: Irritable Bowel Syndrome; Functional Dyspepsia; Functional Abdominal Pain

Treatments: Other: Sugar pill; Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone

Study type: Interventional

Funder types: Other

Identifiers

NCT01269671

CHW 10/102

Details and patient eligibility

About

IND application was submitted to FDA on November 17th.

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Melatonin, Peppermint Oil, Simethicone

Experimental group

Treatment:

Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone

Sugar pill

Placebo Comparator group

Treatment:

Other: Sugar pill