Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain (FAP)
|ClinicalTrials.gov Identifier: NCT01269671|
Recruitment Status : Withdrawn (PI has left institution)
First Posted : January 4, 2011
Last Update Posted : August 24, 2015
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||April 2012|
|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.
- 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.
- Quality of Life [ Time Frame: 8 weeks ]To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
- Anxiety Affects [ Time Frame: 8 weeks ]To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269671
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Adrian Miranda, MD||Medical College of Wisconsin|