Back to resultsGrowth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation
Primary Purpose
Foetal Growth Problem, Small for Gestational Age
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Foetal Growth Problem
Eligibility Criteria
Inclusion Criteria:
- Completion of the GHRETARD/BPD/20/NL trial
- Written informed consent from child and/or parents/guardians before continuation in the extension trial
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose
High dose
Arm Description
Outcomes
Primary Outcome Measures
Linear growth (height during childhood)
Final height
Bone maturation
Pubertal development
Secondary Outcome Measures
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01697644
Brief Title
Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation
Official Title
Growth Hormone Treatment of Children After Intrauterine Growth Retardation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 1990 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (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 and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
Primary Outcome Measure Information:
Title
Linear growth (height during childhood)
Title
Final height
Title
Bone maturation
Title
Pubertal development
Secondary Outcome Measure Information:
Title
Adverse events
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:
Completion of the GHRETARD/BPD/20/NL trial
Written informed consent from child and/or parents/guardians before continuation in the extension trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry B. (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
14671164
Citation
Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A. Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab. 2003 Dec;88(12):5753-8. doi: 10.1210/jc.2003-030512.
Results Reference
result
PubMed Identifier
10487666
Citation
Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial. J Clin Endocrinol Metab. 1999 Sep;84(9):3064-70. doi: 10.1210/jcem.84.9.5942.
Results Reference
result
PubMed Identifier
11061539
Citation
Sas T, Mulder P, Hokken-Koelega A. Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency. J Clin Endocrinol Metab. 2000 Oct;85(10):3786-92. doi: 10.1210/jcem.85.10.6917.
Results Reference
result
PubMed Identifier
11155088
Citation
Sas TC, Gerver WJ, De Bruin R, Mulder PG, Cole TJ, De Waal W, Hokken-Koelega AC. Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial. Clin Endocrinol (Oxf). 2000 Dec;53(6):675-81. doi: 10.1046/j.1365-2265.2000.01155.x.
Results Reference
result
PubMed Identifier
11207640
Citation
Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf). 2001 Feb;54(2):243-51. doi: 10.1046/j.1365-2265.2001.01178.x.
Results Reference
result
PubMed Identifier
12915640
Citation
Van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial. J Clin Endocrinol Metab. 2003 Aug;88(8):3584-90. doi: 10.1210/jc.2002-021172.
Results Reference
result
PubMed Identifier
12519875
Citation
van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab. 2003 Jan;88(1):347-53. doi: 10.1210/jc.2002-020458.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation
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