Clinical trial NCT00163215: Growth Retardation In Children With Special Pathological Conditions Or Disease
Official title: Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endocrine System Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 46
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.


Eligibility criteria: Inclusion Criteria:

* Bone age \< 13 years for a boy and \< 11 years for a girl
* Naive child: Measured Height \< -2.5 SD for CA
* Child currently treated by GH

Exclusion Criteria:

* Idiopathic short stature
* Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

Primary outcomes:
measure: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population
timeFrame: Baseline, Month 36
measure: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population
timeFrame: Baseline, Month 36
Secondary outcomes:
measure: Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Height
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Height at Month 12, Month 24 and Month 36
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population
timeFrame: Baseline, Month 12, Month 24
measure: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population
timeFrame: Baseline, Month 12, Month 24
measure: Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)
timeFrame: Month 12, Month 24, Month 36
measure: Body Mass Index (BMI)
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36
timeFrame: Baseline, Month 12, Month 24, Month 36
measure: Ratio of Bone Age (BA) to Chronological Age (CA)
timeFrame: Baseline, Month 12, Month 24, Month 36
Other outcomes:
Locations:
city: Annemasse Cedex
country: France
facility: Pfizer Investigational Site
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bron Cedex
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Grenoble Cedex
country: France
facility: Pfizer Investigational Site
city: Lorient
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex 05
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: PRINGY Cedex
country: France
facility: Pfizer Investigational Site
city: Toulouse Cedex
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: