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Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

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ClinicalTrials.gov Identifier: NCT01697644
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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).

Condition or disease Intervention/treatment Phase
Foetal Growth Problem Small for Gestational Age Drug: somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Growth Hormone Treatment of Children After Intrauterine Growth Retardation
Study Start Date : October 1990
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Linear growth (height during childhood)
  2. Final height
  3. Bone maturation
  4. Pubertal development

Secondary Outcome Measures :
  1. Adverse events


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

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

Additional Information:
Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01697644     History of Changes
Other Study ID Numbers: GHRETARD/NL/21
First Posted: October 2, 2012    Key Record Dates
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