Back to resultsLong Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation
Primary Purpose
Foetal Growth Problem, Small for Gestational Age
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
somatropin
somatropin
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Foetal Growth Problem
Eligibility Criteria
Inclusion Criteria:
- Patients born with IUGR enrolled in trial GHRETARD/F/1/F
- Bone age below 14 years in boys and 12 years in girls
Exclusion Criteria:
- Bone age above 14 years in boys and 12 years in girls
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1.2, continuous treatment
1.2, non-continuous treatment
2.4, non-continuous treatment
Arm Description
Outcomes
Primary Outcome Measures
Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
Secondary Outcome Measures
Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Pubertal development, assessed according to Tanner method
Height velocity
Final height
Number of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01734447
Brief Title
Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation
Official Title
Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2000 (Actual)
Primary Completion Date
April 30, 2003 (Actual)
Study Completion Date
April 30, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foetal Growth Problem, Small for Gestational Age
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.2, continuous treatment
Arm Type
Experimental
Arm Title
1.2, non-continuous treatment
Arm Type
Experimental
Arm Title
2.4, non-continuous treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
Primary Outcome Measure Information:
Title
Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
Secondary Outcome Measure Information:
Title
Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Title
Pubertal development, assessed according to Tanner method
Title
Height velocity
Title
Final height
Title
Number of Adverse Events
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients born with IUGR enrolled in trial GHRETARD/F/1/F
Bone age below 14 years in boys and 12 years in girls
Exclusion Criteria:
Bone age above 14 years in boys and 12 years in girls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Paris
Country
France
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation
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