Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age
Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR
1 other identifier
interventional
160
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2003
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2005
CompletedFirst Submitted
Initial submission to the registry
November 12, 2007
CompletedFirst Posted
Study publicly available on registry
November 14, 2007
CompletedFebruary 28, 2017
February 1, 2017
1.9 years
November 12, 2007
February 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Height gain according to birth group, age of onset, the treatment and Tanner stage
during 12 months of treatment
Secondary Outcomes (3)
Height SDS for bone age
during 12 months of treatment
Height velocity SDS for bone age
during 12 months of treatment
Height velocity for chronological age
during 12 months of treatment
Interventions
Eligibility Criteria
You may qualify if:
- Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (37)
Novo Nordisk Investigational Site
Albacete, 02006, Spain
Novo Nordisk Investigational Site
Alicante, 03010, Spain
Novo Nordisk Investigational Site
Almería, 04009, Spain
Novo Nordisk Investigational Site
Badajoz, 06080, Spain
Novo Nordisk Investigational Site
Badalona, 08916, Spain
Novo Nordisk Investigational Site
Barcelona, 08009, Spain
Novo Nordisk Investigational Site
Barcelona, 08025, Spain
Novo Nordisk Investigational Site
Calella de La Costa, 08370, Spain
Novo Nordisk Investigational Site
Cáceres, 10002, Spain
Novo Nordisk Investigational Site
Córdoba, 14004, Spain
Novo Nordisk Investigational Site
El Palmar, 30120, Spain
Novo Nordisk Investigational Site
Elche, 3203, Spain
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950, Spain
Novo Nordisk Investigational Site
Getafe, 28905, Spain
Novo Nordisk Investigational Site
Granada, 18012, Spain
Novo Nordisk Investigational Site
Granollers, 08400, Spain
Novo Nordisk Investigational Site
Huelva, 21005, Spain
Novo Nordisk Investigational Site
Jaén, 23007, Spain
Novo Nordisk Investigational Site
Las Palmas, 35016, Spain
Novo Nordisk Investigational Site
Leganés, 28911, Spain
Novo Nordisk Investigational Site
Madrid, 28007, Spain
Novo Nordisk Investigational Site
Madrid, 28009, Spain
Novo Nordisk Investigational Site
Madrid, 28041, Spain
Novo Nordisk Investigational Site
Madrid, 28046, Spain
Novo Nordisk Investigational Site
Martorell, 08760, Spain
Novo Nordisk Investigational Site
Mataró, 08304, Spain
Novo Nordisk Investigational Site
Málaga, 29011, Spain
Novo Nordisk Investigational Site
Palma de Mallorca, 07014, Spain
Novo Nordisk Investigational Site
Pamplona, 31008, Spain
Novo Nordisk Investigational Site
Sabadell, 08208, Spain
Novo Nordisk Investigational Site
Salamanca, 37007, Spain
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, 38010, Spain
Novo Nordisk Investigational Site
Santander, 39008, Spain
Novo Nordisk Investigational Site
Seville, 41014, Spain
Novo Nordisk Investigational Site
Tarrasa, 08227, Spain
Novo Nordisk Investigational Site
Vitoria-Gasteiz, 01009, Spain
Novo Nordisk Investigational Site
Zaragoza, 50009, Spain
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2007
First Posted
November 14, 2007
Study Start
July 28, 2003
Primary Completion
June 29, 2005
Study Completion
June 29, 2005
Last Updated
February 28, 2017
Record last verified: 2017-02