Efficacy on Height in SGA Children Treated With Growth Hormone

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184756
First received: September 13, 2005
Last updated: June 28, 2012
Last verified: June 2012

September 13, 2005
June 28, 2012
November 2002
July 2006   (final data collection date for primary outcome measure)
Evaluate effect on Height in SGA Children Treated with Growth Hormone [ Time Frame: After 2 years of treatment ] [ Designated as safety issue: No ]
Evaluate effect on Height in SGA Children Treated with Growth Hormone after 2 years of treatment
Complete list of historical versions of study NCT00184756 on ClinicalTrials.gov Archive Site
  • Appetite [ Designated as safety issue: No ]
  • Height SDS, yearly [ Designated as safety issue: No ]
  • Appetite
  • Height SDS, yearly
Not Provided
Not Provided
 
Efficacy on Height in SGA Children Treated With Growth Hormone
Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Not Provided
Interventional
Phase 3
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
  • Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion Criteria:

  • Growth Hormone Deficiency (GHD)
  • Treatment with any medical product which may interfere with GH effects
  • Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders
Both
5 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Finland,   Germany,   Israel,   Poland,   Portugal,   Spain,   Sweden
 
NCT00184756
GHLIQUID-1424
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Kirsten Jøns Novo Nordisk A/S
Novo Nordisk A/S
June 2012

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