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

September 28, 2012
October 2, 2012
October 1990
May 2005   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01697644 on ClinicalTrials.gov Archive Site
Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation
Growth Hormone Treatment of Children After Intrauterine Growth Retardation

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Foetal Growth Problem
  • Small for Gestational Age
  • Drug: somatropin
    3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
  • Drug: somatropin
    6 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
  • Experimental: Low dose
    Intervention: Drug: somatropin
  • Experimental: High dose
    Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
3 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01697644
GHRETARD/NL/21
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Christian B. Djurhuus Novo Nordisk A/S
Novo Nordisk A/S
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP