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

This study has been withdrawn prior to enrollment.
(PI has left institution)
Sponsor:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01269671
First received: January 3, 2011
Last updated: August 21, 2015
Last verified: August 2015
  Purpose
IND application was submitted to FDA on November 17th.

Condition Intervention Phase
Functional Abdominal Pain Irritable Bowel Syndrome Functional Dyspepsia Drug: Melatonin, Peppermint Oil (mentharil), and Simethicone Other: Sugar pill Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269671

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Adrian Miranda, MD Medical College of Wisconsin
  More Information

Publications:

Responsible Party: Adrian Miranda, MD (Associate Professor), Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01269671     History of Changes
Other Study ID Numbers: CHW 10/102
Study First Received: January 3, 2011
Last Updated: August 21, 2015

Keywords provided by Medical College of Wisconsin:
Functional Abdominal Pain
Irritable Bowel Syndrome
IBS
Functional Dyspepsia
Melatonin
Simethicone
Peppermint Oil
mentharil
functional bowel disorders
quality of life

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Dyspepsia
Abdominal Pain
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Melatonin
Simethicone
Peppermint oil
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Antifoaming Agents
Emollients
Dermatologic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Parasympatholytics

ClinicalTrials.gov processed this record on July 24, 2017