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

August 1, 2017 updated by: Ismaeel Hashemi, University of Michigan
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • UmichiganHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cyproheptadine first then Placebo
4 weeks of cyproheptadine or placebo with crossover to the other
Drug: Cyproheptadine
4 weeks of cyproheptadine or placebo with crossover to the other
Other Names:
  • Periactin
Drug: sugar pill
4 weeks of cyproheptadine or placebo with crossover to the other
Other Names:
  • placebo
Experimental: Sugar Pill first then Cyprotheptadine
4 weeks of cyproheptadine or placebo with crossover to the other
Drug: Cyproheptadine
4 weeks of cyproheptadine or placebo with crossover to the other
Other Names:
  • Periactin
Drug: sugar pill
4 weeks of cyproheptadine or placebo with crossover to the other
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: at 4 weeks of cyproheptadine or placebo treatment
Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.
at 4 weeks of cyproheptadine or placebo treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Pain
Time Frame: 10 weeks
Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the "Abdominal Pain Index - Child Version" (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Ismaeel Hashemi, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00056045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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