Efficacy on Height in SGA Children Treated With Growth Hormone
Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.
1 other identifier
interventional
151
8 countries
37
Brief Summary
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.
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 Nov 2002
Typical duration for phase_3
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
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJanuary 13, 2017
January 1, 2017
3.7 years
September 13, 2005
January 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate effect on Height in SGA Children Treated with Growth Hormone
After 2 years of treatment
Secondary Outcomes (2)
Appetite
Height SDS, yearly
Interventions
Eligibility Criteria
You may qualify if:
- Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (37)
Novo Nordisk Investigational Site
Brno, 61300, Czechia
Novo Nordisk Investigational Site
Olomouc, 77520, Czechia
Novo Nordisk Investigational Site
Prague, 10081, Czechia
Novo Nordisk Investigational Site
Prague, 116 94, Czechia
Novo Nordisk Investigational Site
Prague, 15006, Czechia
Novo Nordisk Investigational Site
Usti N. Labem, 40011, Czechia
Novo Nordisk Investigational Site
Helsinki, 00029, Finland
Novo Nordisk Investigational Site
Kuopio, 70211, Finland
Novo Nordisk Investigational Site
Oulu, 90029, Finland
Novo Nordisk Investigational Site
Gotha, 99867, Germany
Novo Nordisk Investigational Site
Heidelberg, 69120, Germany
Novo Nordisk Investigational Site
Krefeld, 47805, Germany
Novo Nordisk Investigational Site
Leipzig, 04317, Germany
Novo Nordisk Investigational Site
Wuppertal, 42283, Germany
Novo Nordisk Investigational Site
Beersheba, 84101, Israel
Novo Nordisk Investigational Site
Haifa, 31096, Israel
Novo Nordisk Investigational Site
Petah Tikva, 49202, Israel
Novo Nordisk Investigational Site
Rehovot, 76100, Israel
Novo Nordisk Investigational Site
Gdansk, 80-952, Poland
Novo Nordisk Investigational Site
Krakow, 30-663, Poland
Novo Nordisk Investigational Site
Warsaw, 04-736, Poland
Novo Nordisk Investigational Site
Coimbra, 3000-075, Portugal
Novo Nordisk Investigational Site
Matosinhos Municipality, 4460, Portugal
Novo Nordisk Investigational Site
Porto, 4200-319, Portugal
Novo Nordisk Investigational Site
Vila Nova de Gaia, 4400-129, Portugal
Novo Nordisk Investigational Site
Barcelona, 08035, Spain
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950, Spain
Novo Nordisk Investigational Site
Granada, 18012, Spain
Novo Nordisk Investigational Site
Madrid, 28007, Spain
Novo Nordisk Investigational Site
Madrid, 28009, Spain
Novo Nordisk Investigational Site
Madrid, 28046, Spain
Novo Nordisk Investigational Site
Málaga, 29011, Spain
Novo Nordisk Investigational Site
Santiago de Compostela, 15705, Spain
Novo Nordisk Investigational Site
Valencia, 46026, Spain
Novo Nordisk Investigational Site
Helsingborg, 251 87, Sweden
Novo Nordisk Investigational Site
Örebro, 701 85, Sweden
Novo Nordisk Investigational Site
Stockholm, 171 76, Sweden
Related Publications (1)
Phillip M, Lebl J, Zuckerman-Levin N, Korpal-Szczyrska M, Sales Marques J, Ibáñez L on behalf of the European Norditropin SGA study group. Multinational study in short SGA children: evaluation of the effect of three different growth hormone dose regimens. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki
RESULT
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
November 1, 2002
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
January 13, 2017
Record last verified: 2017-01