Efficacy on Height in SGA Children Treated With Growth Hormone

January 12, 2017 updated by: Novo Nordisk A/S

Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 61300
        • Novo Nordisk Investigational Site
      • Olomouc, Czech Republic, 77520
        • Novo Nordisk Investigational Site
      • Praha 1, Czech Republic, 116 94
        • Novo Nordisk Investigational Site
      • Praha 10, Czech Republic, 10081
        • Novo Nordisk Investigational Site
      • Praha 5, Czech Republic, 15006
        • Novo Nordisk Investigational Site
      • Usti n. Labem, Czech Republic, 40011
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70211
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
  • Germany
      • 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
        • Novo Nordisk Investigational Site
  • Israel
      • 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
        • Novo Nordisk Investigational Site
  • Poland
      • Cracow, Poland, 30-663
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-952
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 04-736
        • Novo Nordisk Investigational Site
  • Portugal
      • 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
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Esplugues Llobregat, Spain, 08950
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28009
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28007
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29011
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15705
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Sweden
      • Helsingborg, Sweden, 251 87
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate effect on Height in SGA Children Treated with Growth Hormone
Time Frame: After 2 years of treatment
After 2 years of treatment

Secondary Outcome Measures

Outcome Measure
Appetite
Height SDS, yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • GHLIQUID-1424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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