Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01697644
First received: September 28, 2012
Last updated: October 2, 2012
Last verified: September 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697644

Locations
Netherlands
Rotterdam, Netherlands, 3015 GJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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
ClinicalTrials.gov 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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014