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

August 21, 2015 updated by: Medical College of Wisconsin
IND application was submitted to FDA on November 17th.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin, Peppermint Oil, Simethicone
Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone
Dosing will be dependent on patient's age during time of enrollment. Patients 8-12 years of age will receive Melatonin 3mg tab at night, Peppermint oil 1 capsule (0.2ml) 30-60 minutes prior to meal twice daily, and Simethicone 80mg tab 30-60 minutes prior to meal twice daily. Patients 13-18 years of age will receive Melatonin 3mg tab at night, Peppermint oil 2 capsules (0.4ml) 30-60 minutes prior to meal twice daily, and Simethicone tab 125mg 30-60 minutes prior to meal twice daily
Placebo Comparator: Sugar pill
Other: Sugar pill
Patients in the placebo group will receive one placebo tab to be taken at night, one placebo capsule to be taken 30-60 minutes prior to meal twice daily, and one placebo tab to be taken 30-60 minutes prior to meal twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction
Time Frame: 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.
8 weeks
Quality of Life
Time Frame: 8 weeks
To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
8 weeks
Anxiety Affects
Time Frame: 8 weeks
To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Adrian Miranda, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 10/102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Dyspepsia

Clinical Trials on Melatonin, Peppermint Oil (mentharil), and Simethicone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe