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

Functional Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01675050
• Other study ID #: HUM00056045
• Status: Recruiting
• Phase: Phase 2
• First received: August 27, 2012
• Last updated: August 29, 2012
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2012
• Source: University of Michigan
• Contact: Emilia Mondragon
• Email: emondrag[@]med.umich.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain

Intervention

Drug:
• Cyproheptadine
4 weeks of cyproheptadine or placebo with crossover to the other
• sugar pill
4 weeks of cyproheptadine or placebo with crossover to the other

Locations

Country	Name	City	State
United States	UmichiganHS	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold	This will be a randomized blinded placebo controlled cross-over study. Forty children aged 8 to 18 years diagnosed with FAP using the Rome III criteria will be recruited. Pressure Pain testing will be performed before and after crossover between drug and placebo to evaluate for objective differences in pressure pain thresholds	10 weeks	Yes
Secondary	Improvement in abdominal pain	Evaluated using surveys.	10 weeks	Yes