This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Cyproheptadine as an Appetite Stimulant

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:


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

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

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

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   (Child)
Sexes Eligible for Study:   All
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
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: 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

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

Additional relevant MeSH terms:
Failure to Thrive
Signs and Symptoms
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