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

Primary Purpose

Functional Abdominal Pain, Irritable Bowel Syndrome, Functional Dyspepsia

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melatonin, Peppermint Oil (mentharil), and Simethicone
Sugar pill
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Abdominal Pain focused on measuring Functional Abdominal Pain, Irritable Bowel Syndrome, IBS, Functional Dyspepsia, Melatonin, Simethicone, Peppermint Oil, mentharil, functional bowel disorders, quality of life

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin, Peppermint Oil, Simethicone

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Pain Reduction
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
To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
Anxiety Affects
To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2011
Last Updated
August 21, 2015
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01269671
Brief Title
Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain
Acronym
FAP
Official Title
Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI has left institution
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
IND application was submitted to FDA on November 17th.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain, Irritable Bowel Syndrome, Functional Dyspepsia
Keywords
Functional Abdominal Pain, Irritable Bowel Syndrome, IBS, Functional Dyspepsia, Melatonin, Simethicone, Peppermint Oil, mentharil, functional bowel disorders, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin, Peppermint Oil, Simethicone
Arm Type
Experimental
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Melatonin, Peppermint Oil (mentharil), and Simethicone
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Reduction
Description
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.
Time Frame
8 weeks
Title
Quality of Life
Description
To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
Time Frame
8 weeks
Title
Anxiety Affects
Description
To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Miranda, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19038403
Citation
Saps M, Seshadri R, Sztainberg M, Schaffer G, Marshall BM, Di Lorenzo C. A prospective school-based study of abdominal pain and other common somatic complaints in children. J Pediatr. 2009 Mar;154(3):322-6. doi: 10.1016/j.jpeds.2008.09.047. Epub 2008 Nov 28.
Results Reference
background
PubMed Identifier
16396860
Citation
Youssef NN, Murphy TG, Langseder AL, Rosh JR. Quality of life for children with functional abdominal pain: a comparison study of patients' and parents' perceptions. Pediatrics. 2006 Jan;117(1):54-9. doi: 10.1542/peds.2005-0114.
Results Reference
background
PubMed Identifier
19104969
Citation
Schurman JV, Danda CE, Friesen CA, Hyman PE, Simon SD, Cocjin JT. Variations in psychological profile among children with recurrent abdominal pain. J Clin Psychol Med Settings. 2008 Sep;15(3):241-51. doi: 10.1007/s10880-008-9120-0. Epub 2008 Jul 25.
Results Reference
background
PubMed Identifier
16049263
Citation
White KS, Farrell AD. Anxiety and psychosocial stress as predictors of headache and abdominal pain in urban early adolescents. J Pediatr Psychol. 2006 Jul;31(6):582-96. doi: 10.1093/jpepsy/jsj050. Epub 2005 Jul 27.
Results Reference
background
PubMed Identifier
19596010
Citation
Saps M, Youssef N, Miranda A, Nurko S, Hyman P, Cocjin J, Di Lorenzo C. Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders. Gastroenterology. 2009 Oct;137(4):1261-9. doi: 10.1053/j.gastro.2009.06.060. Epub 2009 Jul 31.
Results Reference
background
PubMed Identifier
17426465
Citation
Klupinska G, Poplawski T, Drzewoski J, Harasiuk A, Reiter RJ, Blasiak J, Chojnacki J. Therapeutic effect of melatonin in patients with functional dyspepsia. J Clin Gastroenterol. 2007 Mar;41(3):270-4. doi: 10.1097/MCG.0b013e318031457a.
Results Reference
background
PubMed Identifier
15914575
Citation
Song GH, Leng PH, Gwee KA, Moochhala SM, Ho KY. Melatonin improves abdominal pain in irritable bowel syndrome patients who have sleep disturbances: a randomised, double blind, placebo controlled study. Gut. 2005 Oct;54(10):1402-7. doi: 10.1136/gut.2004.062034. Epub 2005 May 24.
Results Reference
background
PubMed Identifier
20413219
Citation
Mickle A, Sood M, Zhang Z, Shahmohammadi G, Sengupta JN, Miranda A. Antinociceptive effects of melatonin in a rat model of post-inflammatory visceral hyperalgesia: a centrally mediated process. Pain. 2010 Jun;149(3):555-564. doi: 10.1016/j.pain.2010.03.030. Epub 2010 Apr 21.
Results Reference
background
PubMed Identifier
11148527
Citation
Kline RM, Kline JJ, Di Palma J, Barbero GJ. Enteric-coated, pH-dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. J Pediatr. 2001 Jan;138(1):125-8. doi: 10.1067/mpd.2001.109606.
Results Reference
background
PubMed Identifier
9524891
Citation
Voepel-Lewis TD, Malviya S, Burke C, D'Agostino R, Hadden SM, Siewert M, Tait AR. Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants. J Clin Anesth. 1998 Mar;10(2):91-4. doi: 10.1016/s0952-8180(97)00249-3.
Results Reference
background
PubMed Identifier
10333820
Citation
Kaplan MA, Prior MJ, Ash RR, McKonly KI, Helzner EC, Nelson EB. Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial. Arch Fam Med. 1999 May-Jun;8(3):243-8. doi: 10.1001/archfami.8.3.243.
Results Reference
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Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

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