NCT01269671

Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

IND application was submitted to FDA on November 17th.

Conditions

• Functional Abdominal Pain
• Irritable Bowel Syndrome
• Functional Dyspepsia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2012-04-01
• First posted: 2011-01-04
• Last updated: 2015-08-24

Locations

1 site across 1 country: United States