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A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Functional Abdominal Pain

Intervention: Cyproheptadine (Drug); sugar pill (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Michigan

Overall contact:
Emilia Mondragon, Email: emondrag@med.umich.edu

Summary

The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with FAP in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain and other symptoms, the investigators also propose to perform experimental somatic pain testing to determine if there is evidence of peripherally-maintained central sensitization in children with FAP. The investigators also hypothesize that there will be an increase in somatic pain threshold after completion of a Cyproheptadine course compared to baseline testing prior to treatment, and compared to placebo. This would allow children with FAP to return to normal function, improve symptoms and overall general well-being

Clinical Details

Official title: A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pressure Pain Threshold

Secondary outcome: Improvement in abdominal pain

Eligibility

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age between 8 and 18 years-old

- Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include

all* of the following: 1. Episodic or continuous abdominal pain 2. Insufficient criteria for other FGIDs 3. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms

- Criteria fulfilled at least once per week for at least 2 months prior to

diagnosis

- Written informed consent obtained from the patient/guardian before the initiation of

any study-specific procedures Exclusion Criteria:

- Age < 8 years-old or Age >18 years-old

- Child or parent are non-English speakers

- Child is using other CNS depressants (cyproheptadine causes drowsiness, and may

enhance the adverse/toxic effect of other CNS Depressants e. g. opioids, barbiturates, Droperidol, Hydroxyzine, Alcohol)(29)

- Child has a history of hypersensitivity to Cyproheptadine products

- Child is currently using monoamine oxidase inhibitor (MAOI e. g. Nardil, Marplan,

Parnate) (can cause a prolonged or intensified anticholinergic effect)

- Child was treated with Cyproheptadine in the past 4 weeks

- Child is currently using anticholinergic (can cause an additive anticholinergic

effect e. g. Pramlintide)

- Concomitant SSRI use ( being a serotonin antagonist, may oppose effects)

- Concomitant use of Betahistine: Antihistamines may diminish the therapeutic effect of

Betahistine

- Concomitant use of Acetylcholinesterase Inhibitors (Central): Anticholinergics may

diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central) and vice versa.

- Child has a personal history of glaucoma

- Child has asthma (can cause thickening of bronchial secretions) (27,28)

- History of liver dysfunction/disease (can cause hepatitis)

- History of cardiac disease (not specific to Cyproheptadine, antihistamines have been

associated with hypotension, palpitations, tachycardia and arrhythmias) (28,29).

- Females who are known to be pregnant will also be excluded. All females who are of

child bearing age, or are already menstruating will perform a urine pregnancy test before enrolling.

- Any children who have difficulties swallowing tablets will receive teaching on how to

swallow tablets. If they are still unable to do so, they will not participate in the study.

Locations and Contacts

Emilia Mondragon, Email: emondrag@med.umich.edu

UmichiganHS, Ann Arbor, Michigan 48105, United States; Recruiting
Emilia Mondragon, Email: emondrag@med.umich.edu
Ismaeel Hashemi, MD, Principal Investigator
Additional Information

Starting date: August 2012
Last updated: August 29, 2012

Page last updated: August 20, 2015

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