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

NCT01675050 | Terminated Phase 2 Results DMC

• 1 other identifier: HUM00056045
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold

  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 Outcomes (1)

• Abdominal Pain

  10 weeks

Study Arms (2)

Cyproheptadine first then Placebo

EXPERIMENTAL

4 weeks of cyproheptadine or placebo with crossover to the other

Drug: Cyproheptadine; Drug: sugar pill

Sugar Pill first then Cyprotheptadine

EXPERIMENTAL

4 weeks of cyproheptadine or placebo with crossover to the other

Drug: Cyproheptadine; Drug: sugar pill

Interventions

Cyproheptadine DRUG

4 weeks of cyproheptadine or placebo with crossover to the other

Also known as: Periactin

Cyproheptadine first then Placebo; Sugar Pill first then Cyprotheptadine

sugar pill DRUG

4 weeks of cyproheptadine or placebo with crossover to the other

Also known as: placebo

Cyproheptadine first then Placebo; Sugar Pill first then Cyprotheptadine

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

UmichiganHS

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Interventions

Cyproheptadine; Sugars

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

Statistical analyses were not conducted due to small sample size. Results should be interpreted with extreme caution.

Results Point of Contact

• Title: Ismaeel Hashemi, M.D. Principal Investigator
• Organization: University of Michigan

ismaeel.hashemi@gmail.com

6169165566

Study Officials

• Ismaeel Hashemi, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Physician

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 30, 2017
• Results First Posted: June 21, 2017

Record last verified: 2017-08

Locations

US (1)