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Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

NCT01269671 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-08-24

No results posted yet for this study

Summary

IND application was submitted to FDA on November 17th.

Conditions

  • Functional Abdominal Pain
  • Irritable Bowel Syndrome
  • Functional Dyspepsia

Interventions

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

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Adrian Miranda, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269671 on ClinicalTrials.gov