Back to resultsMAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
Primary Purpose
Fetal Growth Retardation
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Growth Retardation
Eligibility Criteria
Inclusion Criteria:
- Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
- Height Less Than or Equal to -3 SD
Exclusion Criteria:
- Age less than 3 years
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Efficacy data : measurement of height
Secondary Outcome Measures
laboratory test assessment and evaluation of bone age
measurement of anti-GH and anti-ECP antibodies
Tolerance data : undesirable events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452491
Brief Title
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
Official Title
A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
May 1993 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
To specify the best period of treatment
To assess the efficacy of treatment based on final adult height of these children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
0.2 IU/kg/day 7 days per week given continuously for 3 years
Primary Outcome Measure Information:
Title
Efficacy data : measurement of height
Time Frame
at trimestrial visit
Secondary Outcome Measure Information:
Title
laboratory test assessment and evaluation of bone age
Time Frame
at every other visit
Title
measurement of anti-GH and anti-ECP antibodies
Time Frame
one visit out of four
Title
Tolerance data : undesirable events
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
Height Less Than or Equal to -3 SD
Exclusion Criteria:
Age less than 3 years
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie SEBILLE, Dr
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
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