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
  Purpose

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.


Condition Intervention Phase
Foetal Growth Problem
Small for Gestational Age
Drug: somatropin
Phase 3

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: Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Evaluate effect on Height in SGA Children Treated with Growth Hormone [ Time Frame: After 2 years of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appetite [ Designated as safety issue: No ]
  • Height SDS, yearly [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: November 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184756

Locations
Czech Republic
Prague, Czech Republic
Finland
Fin-HUS, Finland
Germany
Leipzig, Germany
Israel
Be'er Sheva, Israel
Poland
Warszawa, Poland
Portugal
Porto, Portugal
Spain
Madrid, Spain
Sweden
Stockholm, Sweden
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Kirsten Jøns 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: NCT00184756     History of Changes
Other Study ID Numbers: GHLIQUID-1424
Study First Received: September 13, 2005
Last Updated: June 28, 2012
Health Authority: Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014