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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Medical College of Wisconsin.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01269671
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Pain Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate improvement in quality of life in children treated with combination therapy versus placebo.

  • Anxiety Affects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: April 2012
Estimated 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269671

Contacts
Contact: Adrian Miranda, MD 414-266-3690

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Adrian Miranda, MD     414-266-3690        
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: January 3, 2011
Health Authority: United States: Food and Drug Administration

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:
Abdominal Pain
Dyspepsia
Irritable Bowel Syndrome
Gastritis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases
Melatonin
 Peppermint oil
Simethicone
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Emollients
Dermatologic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013