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Cyproheptadine as an Appetite Stimulant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by St. Justine's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01314989
First received: March 14, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Failure to Thrive
 Drug: Cyproheptadine
Drug: Sugar pill
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Weight gain [ Time Frame: January 2011 to January 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feeding behaviour [ Time Frame: January 2011 to January 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cyproheptadine
Cross-over study
 Drug: Cyproheptadine
0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month
Placebo Comparator: Sugar pill
Cross-over study
 Drug: Sugar pill
liquid placebo

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314989

Locations
Canada, Quebec
Ste-Justine University Health Center Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Valerie Marchand, MD     5143454931 ext 3562     valerie_marchand@ssss.gouv.qc.ca    
Principal Investigator: Valerie Marchand, MD            
Principal Investigator: Veronique Groleau, MD            
Sponsors and Collaborators
St. Justine's Hospital
  More Information

No publications provided

Responsible Party: Dr Valerie Marchand, Ste-Justine University Health Center
ClinicalTrials.gov Identifier: NCT01314989     History of Changes
Other Study ID Numbers: Cypro-24
Study First Received: March 14, 2011
Last Updated: March 14, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Failure to Thrive
Growth Disorders
Pathologic Processes
Cyproheptadine
Appetite Stimulants
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013