CClinicalTrials.gg
CompletedNCT00184756Updated Jan 13, 2017

Efficacy on Height in SGA Children Treated With Growth Hormone

A Phase 3 interventional study of somatropin in Foetal Growth Problem and Small for Gestational Age, sponsored by Novo Nordisk A/S. Completed at 37 sites in 8 countries. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2017-01-13.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
3 Years to 7 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Foetal Growth Problem
  • Small for Gestational Age
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
151 participants (actual)

Interventions

  • Drugsomatropin
06

What researchers measure

Primary outcomes

  1. Evaluate effect on Height in SGA Children Treated with Growth Hormone

    Time frame: After 2 years of treatment

Secondary outcomes

  1. Appetite

  2. Height SDS, yearly

07

Study locations

37 sites
  • Novo Nordisk Investigational Site
    Brno, 61300, Czech Republic
  • Novo Nordisk Investigational Site
    Olomouc, 77520, Czech Republic
  • Novo Nordisk Investigational Site
    Praha 10, 10081, Czech Republic
  • Novo Nordisk Investigational Site
    Praha 1, 116 94, Czech Republic
  • Novo Nordisk Investigational Site
    Praha 5, 15006, Czech Republic
  • Novo Nordisk Investigational Site
    Usti n. Labem, 40011, Czech Republic
  • 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
    Beer Sheva, 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
    Cracow, 30-663, Poland
  • Novo Nordisk Investigational Site
    Gdansk, 80-952, Poland
  • Novo Nordisk Investigational Site
    Warszawa, 04-736, Poland
  • Novo Nordisk Investigational Site
    Coimbra, 3000-075, Portugal
  • Novo Nordisk Investigational Site
    Matosinhos, 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
    Stockholm, 171 76, Sweden
  • Novo Nordisk Investigational Site
    Örebro, 701 85, Sweden
08

References and documents

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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00184756
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Nov 2002
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Jan 13, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion