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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00557336
First received: November 12, 2007
Last updated: February 27, 2017
Last verified: February 2017
  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
Intervention Model: Single Group Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Height SDS for bone age [ Time Frame: during 12 months of treatment ]
  • Height velocity SDS for bone age [ Time Frame: during 12 months of treatment ]
  • Height velocity for chronological age [ Time Frame: during 12 months of treatment ]

Enrollment: 160
Actual Study Start Date: July 28, 2003
Study Completion Date: June 29, 2005
Primary Completion Date: June 29, 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Novo Nordisk Investigational Site
Albacete, Spain, 02006
Novo Nordisk Investigational Site
Alicante, Spain, 03010
Novo Nordisk Investigational Site
Almería, Spain, 04009
Novo Nordisk Investigational Site
Badajoz, Spain, 06080
Novo Nordisk Investigational Site
Badalona, Spain, 08916
Novo Nordisk Investigational Site
Barcelona, Spain, 08009
Novo Nordisk Investigational Site
Barcelona, Spain, 08025
Novo Nordisk Investigational Site
Calella de la Costa, Spain, 08370
Novo Nordisk Investigational Site
Cáceres, Spain, 10002
Novo Nordisk Investigational Site
Córdoba, Spain, 14004
Novo Nordisk Investigational Site
El Palmar, Spain, 30120
Novo Nordisk Investigational Site
Elche, Spain, 3203
Novo Nordisk Investigational Site
Esplugues Llobregat, Spain, 08950
Novo Nordisk Investigational Site
Getafe, Spain, 28905
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Granollers, Spain, 08400
Novo Nordisk Investigational Site
Huelva, Spain, 21005
Novo Nordisk Investigational Site
Jaén, Spain, 23007
Novo Nordisk Investigational Site
Las Palmas, Spain, 35016
Novo Nordisk Investigational Site
Leganés, Spain, 28911
Novo Nordisk Investigational Site
Madrid, Spain, 28007
Novo Nordisk Investigational Site
Madrid, Spain, 28009
Novo Nordisk Investigational Site
Madrid, Spain, 28041
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Martorell, Spain, 08760
Novo Nordisk Investigational Site
Mataró, Spain, 08304
Novo Nordisk Investigational Site
Málaga, Spain, 29011
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07014
Novo Nordisk Investigational Site
Pamplona, Spain, 31008
Novo Nordisk Investigational Site
Sabadell, Spain, 08208
Novo Nordisk Investigational Site
Salamanca, Spain, 37007
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, Spain, 38010
Novo Nordisk Investigational Site
Santander, Spain, 39008
Novo Nordisk Investigational Site
Sevilla, Spain, 41014
Novo Nordisk Investigational Site
Tarrasa, Spain, 08227
Novo Nordisk Investigational Site
Vitoria, Spain, 01009
Novo Nordisk Investigational Site
Zaragoza, Spain, 50009
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: 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: February 27, 2017

ClinicalTrials.gov processed this record on April 28, 2017