NCT01314989

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

March 14, 2011

Last Update Submit

March 14, 2011

Conditions

Failure to Thrive

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    January 2011 to January 2012

Secondary Outcomes (1)

  • Feeding behaviour

    January 2011 to January 2012

Study Arms (2)

Cyproheptadine

ACTIVE COMPARATOR

Cross-over study

Drug: Cyproheptadine

Sugar pill

PLACEBO COMPARATOR

Cross-over study

Drug: Sugar pill

Interventions

CyproheptadineDRUG

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

Cyproheptadine
Sugar pillDRUG

liquid placebo

Sugar pill

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 4 years of age
  • failure to thrive

You may not qualify if:

  • Medication affecting appetite
  • Medication interacting with Cyproheptadine
  • Prematurity under 36 weeks of gestation
  • Neurologic impairment
  • underlying organic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ste-Justine University Health Center

Montreal, Quebec, H3T1C5, Canada

RECRUITING

MeSH Terms

Conditions

Failure to Thrive

Interventions

CyproheptadineSugars

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

January 1, 2012

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

CA(1)