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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01269671

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

IND application was submitted to FDA on November 17th.

Condition or Disease	Intervention/Treatment	Phase
Functional Abdominal Pain Irritable Bowel Syndrome Functional Dyspepsia	Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone Other: Sugar pill	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.