Cyproheptadine as an Appetite Stimulant

NCT ID: NCT01314989

Last Updated: 2011-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-01-31

Brief Summary

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Cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. Otherwise, no randomised control trial demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. Our hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.

Detailed Description

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Conditions

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Failure to Thrive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cyproheptadine

Cross-over study

Group Type ACTIVE_COMPARATOR

Cyproheptadine

Intervention Type DRUG

0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month

Sugar pill

Cross-over study

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

liquid placebo

Interventions

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Cyproheptadine

0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month

Intervention Type DRUG

Sugar pill

liquid placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 2 to 4 years of age
* failure to thrive

Exclusion Criteria

* Medication affecting appetite
* Medication interacting with Cyproheptadine
* Prematurity under 36 weeks of gestation
* Neurologic impairment
* underlying organic disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ste-Justine University Health Center

Locations

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Ste-Justine University Health Center

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Valerie Marchand, MD

Role: primary

5143454931 ext. 3562

Other Identifiers

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Cypro-24

Identifier Type: -

Identifier Source: org_study_id

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