Failure to ThrivePhase 4NCT01314989
Cyproheptadine as an Appetite Stimulant
A Phase 4 study testing Cyproheptadine and Sugar pill in people with Failure to Thrive, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Failure to Thrive
- What is being tested?
- Cyproheptadine and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2 to 4 years of age
- failure to thrive
Who cannot join
- Medication affecting appetite
- Medication interacting with Cyproheptadine
- Prematurity under 36 weeks of gestation
- Neurologic impairment
- underlying organic disease
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ste-Justine University Health Center
Montreal, Quebec, H3T1C5
Valerie Marchand, MD, 5143454931 ext. 3562, valerie_marchand@ssss.gouv.qc.ca
Valerie Marchand, MD
About this study
Official title: Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive
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.
- Conditions
- Failure to Thrive
- Being tested
- Cyproheptadine, Sugar pill
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyproheptadineDrug
0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month
Sugar pillDrug
liquid placebo
| Study group | Role | What they receive |
|---|---|---|
| Cyproheptadine | Active comparator | Cross-over study Receives: Drug: Cyproheptadine |
| Sugar pill | Placebo comparator | Cross-over study Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: January 2011 to January 2012
Secondary outcomes (1)
Feeding behaviour
Measured: January 2011 to January 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314989
- Sponsor's protocol ID
- Cypro-24
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive
- ClinicalTrials.gov ID
- NCT01314989
- Acronym / sponsor ID
- Cypro-24
- Conditions
- Failure to Thrive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyproheptadine | Active comparator | Drug: CyproheptadineCross-over study |
| Sugar pill | Placebo comparator | Drug: Sugar pillCross-over study |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2 to 4 years of age
- failure to thrive
Key exclusion criteria (5 listed)
- Medication affecting appetite
- Medication interacting with Cyproheptadine
- Prematurity under 36 weeks of gestation
- Neurologic impairment
- underlying organic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyproheptadine0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month | Drug | Cyproheptadine |
| Sugar pillliquid placebo | Drug | Sugar pill |
Primary outcome
Weight gain
Time frame: January 2011 to January 2012
1 secondary outcome
Feeding behaviour
Time frame: January 2011 to January 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
Related trials for Failure to Thrive
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Not yet recruiting
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Faltering Growth, Failure to Thrive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ste-Justine University Health Center
Montreal, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyproheptadine and Sugar pill in people with Failure to Thrive, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: January 2011 to January 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2011.