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

This study has been terminated.
(Due to the wide availability of the drug in clinical practice, it was impossible to recruit adequate numbers for scientific power.)
Sponsor:
Information provided by (Responsible Party):
Ismaeel Hashemi, University of Michigan
ClinicalTrials.gov Identifier:
NCT01675050
First received: August 27, 2012
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
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

Condition Intervention Phase
Functional Abdominal Pain Drug: Cyproheptadine Drug: sugar pill Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain

Resource links provided by NLM:


Further study details as provided by Ismaeel Hashemi, University of Michigan:

Primary Outcome Measures:
  • Pressure Pain Threshold [ Time Frame: 10 weeks ]
    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.


Secondary Outcome Measures:
  • 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).


Enrollment: 4
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Periactin
Drug: sugar pill
4 weeks of cyproheptadine or placebo with crossover to the other
Other Name: 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 Name: Periactin
Drug: sugar pill
4 weeks of cyproheptadine or placebo with crossover to the other
Other Name: placebo

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675050

Locations
United States, Michigan
UmichiganHS
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ismaeel Hashemi, MD University of Michigan
  More Information

Responsible Party: Ismaeel Hashemi, Fellow Physician, University of Michigan
ClinicalTrials.gov Identifier: NCT01675050     History of Changes
Other Study ID Numbers: HUM00056045
Study First Received: August 27, 2012
Results First Received: May 26, 2017
Last Updated: May 26, 2017

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Cyproheptadine
Antipruritics
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on June 23, 2017