Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00557336
First received: November 12, 2007
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Height gain according to birth group, age of onset, the treatment and Tanner stage [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height SDS for bone age [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]
  • Height velocity SDS for bone age [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]
  • Height velocity for chronological age [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: July 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
  • Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
  • Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
  • Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria:

  • Diabetes
  • Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
  • Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
  • History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
  • Previous or ongoing growth hormone therapy
  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: NCT00557336

Locations
Spain
Madrid, Spain, 28041
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Llanos Moreno, PhD Novo Nordisk Pharma SA
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00557336     History of Changes
Other Study ID Numbers: GHLIQUID-1523
Study First Received: November 12, 2007
Last Updated: June 28, 2012
Health Authority: Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on July 24, 2014