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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014