Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Small for Gestational Age Clinical Trial

Official title:

Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697644
• Other study ID #: GHRETARD/NL/21
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2012
• Last updated: January 17, 2017
• Start date: October 1990
• Est. completion date: May 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
• somatropin
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Rotterdam
Netherlands	Novo Nordisk Investigational Site	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View 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 — View 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. — View 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 — View 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 — View 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 tria — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear growth (height during childhood)
Primary	Final height
Primary	Bone maturation
Primary	Pubertal development
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk