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Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697644
First Posted: October 2, 2012
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
  • Final height
  • Bone maturation
  • Pubertal development

Secondary Outcome Measures:
  • Adverse events

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697644


Locations
Netherlands
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 CN
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 GJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry B. (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01697644     History of Changes
Other Study ID Numbers: GHRETARD/NL/21
First Submitted: September 28, 2012
First Posted: October 2, 2012
Last Update Posted: January 18, 2017
Last Verified: January 2017

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