NCT01269671

Brief Summary

IND application was submitted to FDA on November 17th.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

January 3, 2011

Last Update Submit

August 21, 2015

Conditions

Functional Abdominal PainIrritable Bowel SyndromeFunctional Dyspepsia

Keywords

Functional Abdominal PainIrritable Bowel SyndromeIBSFunctional DyspepsiaMelatoninSimethiconePeppermint Oilmentharilfunctional bowel disordersquality of life

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 weeks

  • Quality of Life

    To evaluate improvement in quality of life in children treated with combination therapy versus placebo.

    8 weeks

  • Anxiety Affects

    To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.

    8 weeks

Study Arms (2)

Melatonin, Peppermint Oil, Simethicone

EXPERIMENTAL
Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone

Sugar pill

PLACEBO COMPARATOR
Other: Sugar pill

Interventions

Melatonin, Peppermint Oil (mentharil), and SimethiconeDRUG

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

Melatonin, Peppermint Oil, Simethicone
Sugar pillOTHER

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.

Sugar pill

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (11)

  • 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.

    PMID: 19038403BACKGROUND

  • 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.

    PMID: 16396860BACKGROUND

  • 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.

    PMID: 19104969BACKGROUND

  • 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.

    PMID: 16049263BACKGROUND

  • 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.

    PMID: 19596010BACKGROUND

  • 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.

    PMID: 17426465BACKGROUND

  • 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.

    PMID: 15914575BACKGROUND

  • 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.

    PMID: 20413219BACKGROUND

  • 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.

    PMID: 11148527BACKGROUND

  • 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.

    PMID: 9524891BACKGROUND

  • 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.

    PMID: 10333820BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Melatoninpeppermint oilSimethiconeSugars

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCarbohydrates

Study Officials

  • Adrian Miranda, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(1)