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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Functional Abdominal Pain

In brief

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

Key facts

Study ID

NCT01675050

Run by

University of Michigan

People needed

4

Starts

2012-08-01

Expected to finish

2013-08-01

Last updated by the study team

2017-08-30

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 8 and 18 years-old
• Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include all* of the following:
• Episodic or continuous abdominal pain
• Insufficient criteria for other FGIDs
• 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

You may not qualify if…

• 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.

Where it is running

• UmichiganHS — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.