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Cyproheptadine as an Appetite Stimulant

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ClinicalTrials.gov Identifier: NCT01314989
Recruitment Status : Unknown
Verified March 2011 by St. Justine's Hospital.
Recruitment status was:  Recruiting
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Information provided by:
St. Justine's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Failure to Thrive Drug: Cyproheptadine Drug: Sugar pill Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Weight gain [ Time Frame: January 2011 to January 2012 ]

Secondary Outcome Measures :
  1. Feeding behaviour [ Time Frame: January 2011 to January 2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314989

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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
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Responsible Party: Dr Valerie Marchand, Ste-Justine University Health Center
ClinicalTrials.gov Identifier: NCT01314989    
Other Study ID Numbers: Cypro-24
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Failure to Thrive
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