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

NCT ID: NCT01675050

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

Brief Summary

The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (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

Conditions

Functional Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cyproheptadine first then Placebo

4 weeks of cyproheptadine or placebo with crossover to the other

Group Type: EXPERIMENTAL

Cyproheptadine

Intervention Type: DRUG

4 weeks of cyproheptadine or placebo with crossover to the other

sugar pill

Intervention Type: DRUG

4 weeks of cyproheptadine or placebo with crossover to the other

Sugar Pill first then Cyprotheptadine

4 weeks of cyproheptadine or placebo with crossover to the other

Group Type: EXPERIMENTAL

Cyproheptadine

Intervention Type: DRUG

4 weeks of cyproheptadine or placebo with crossover to the other

sugar pill

Intervention Type: DRUG

4 weeks of cyproheptadine or placebo with crossover to the other

Interventions

Cyproheptadine

4 weeks of cyproheptadine or placebo with crossover to the other

Intervention Type: DRUG

sugar pill

4 weeks of cyproheptadine or placebo with crossover to the other

Intervention Type: DRUG

Other Intervention Names

Periactin; placebo

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ismaeel Hashemi

Fellow Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismaeel Hashemi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

UmichiganHS

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00056045

Identifier Type: -

Identifier Source: org_study_id