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Efficacy on Height in SGA Children Treated With Growth Hormone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00184756
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Foetal Growth Problem Small for Gestational Age Drug: somatropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.
Study Start Date : November 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




Primary Outcome Measures :
  1. Evaluate effect on Height in SGA Children Treated with Growth Hormone [ Time Frame: After 2 years of treatment ]

Secondary Outcome Measures :
  1. Appetite
  2. Height SDS, yearly


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184756


Locations
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Czech Republic
Novo Nordisk Investigational Site
Brno, Czech Republic, 61300
Novo Nordisk Investigational Site
Olomouc, Czech Republic, 77520
Novo Nordisk Investigational Site
Praha 10, Czech Republic, 10081
Novo Nordisk Investigational Site
Praha 1, Czech Republic, 116 94
Novo Nordisk Investigational Site
Praha 5, Czech Republic, 15006
Novo Nordisk Investigational Site
Usti n. Labem, Czech Republic, 40011
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00029
Novo Nordisk Investigational Site
Kuopio, Finland, 70211
Novo Nordisk Investigational Site
Oulu, Finland, 90029
Germany
Novo Nordisk Investigational Site
Gotha, Germany, 99867
Novo Nordisk Investigational Site
Heidelberg, Germany, 69120
Novo Nordisk Investigational Site
Krefeld, Germany, 47805
Novo Nordisk Investigational Site
Leipzig, Germany, 04317
Novo Nordisk Investigational Site
Wuppertal, Germany, 42283
Israel
Novo Nordisk Investigational Site
Beer Sheva, Israel, 84101
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Novo Nordisk Investigational Site
Rehovot, Israel, 76100
Poland
Novo Nordisk Investigational Site
Cracow, Poland, 30-663
Novo Nordisk Investigational Site
Gdansk, Poland, 80-952
Novo Nordisk Investigational Site
Warszawa, Poland, 04-736
Portugal
Novo Nordisk Investigational Site
Coimbra, Portugal, 3000-075
Novo Nordisk Investigational Site
Matosinhos, Portugal, 4460
Novo Nordisk Investigational Site
Porto, Portugal, 4200-319
Novo Nordisk Investigational Site
Vila Nova de Gaia, Portugal, 4400-129
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Esplugues Llobregat, Spain, 08950
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Madrid, Spain, 28007
Novo Nordisk Investigational Site
Madrid, Spain, 28009
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Málaga, Spain, 29011
Novo Nordisk Investigational Site
Santiago de Compostela, Spain, 15705
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sweden
Novo Nordisk Investigational Site
Helsingborg, Sweden, 251 87
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
Novo Nordisk Investigational Site
Örebro, Sweden, 701 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184756    
Other Study ID Numbers: GHLIQUID-1424
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017