Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: September 28, 2012
Last updated: October 2, 2012
Last verified: September 2012

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).

Condition Intervention Phase
Foetal Growth Problem
Small for Gestational Age
Drug: somatropin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Linear growth (height during childhood) [ Designated as safety issue: No ]
  • Final height [ Designated as safety issue: No ]
  • Bone maturation [ Designated as safety issue: No ]
  • Pubertal development [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: October 1990
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose Drug: somatropin
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
Experimental: High dose Drug: somatropin
6 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily


Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01697644

Rotterdam, Netherlands, 3015 GJ
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Christian B. Djurhuus Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01697644     History of Changes
Other Study ID Numbers: GHRETARD/NL/21
Study First Received: September 28, 2012
Last Updated: October 2, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014