Cyproheptadine as an Appetite Stimulant | NCT01314989

Studies
Cyproheptadine as an Appetite Stimulant

NCT01314989

Sponsor

St. Justine's Hospital

Status

Unknown status

Last Update Posted

Mar 15, 2011Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Failure to Thrive

Interventions

Cyproheptadine
Sugar pill

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Mar 14, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2011

Last Update Posted Date

Mar 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cyproheptadine	Active Comparator	Cross-over study	Drug: Cyproheptadine
Sugar pill	Placebo Comparator	Cross-over study	Drug: Sugar pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyproheptadine	Drug	0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month	Cyproheptadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight gain		January 2011 to January 2012

Secondary Outcomes

Measure	Description	Time Frame
Feeding behaviour		January 2011 to January 2012

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ste-Justine University Health Center	Recruiting	Montreal	Quebec	H3T1C5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D005183	Failure to Thrive

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003533	Cyproheptadine
D000073893	Sugars

Ancestor Terms

ID	Term
D003986	Dibenzocycloheptenes
D001567	Benzocycloheptenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided