Efficacy on Height in SGA Children Treated With Growth Hormone

NCT ID: NCT00184756

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Foetal Growth Problem Small for Gestational Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Brno, , Czechia

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Usti N. Labem, , Czechia

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Novo Nordisk Investigational Site

Helsinki, , Finland

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Novo Nordisk Investigational Site

Kuopio, , Finland

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Novo Nordisk Investigational Site

Oulu, , Finland

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Novo Nordisk Investigational Site

Gotha, , Germany

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Novo Nordisk Investigational Site

Heidelberg, , Germany

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Novo Nordisk Investigational Site

Krefeld, , Germany

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Novo Nordisk Investigational Site

Leipzig, , Germany

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Novo Nordisk Investigational Site

Wuppertal, , Germany

Site Status

Novo Nordisk Investigational Site

Beersheba, , Israel

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Novo Nordisk Investigational Site

Haifa, , Israel

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Novo Nordisk Investigational Site

Petah Tikva, , Israel

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Novo Nordisk Investigational Site

Rehovot, , Israel

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Novo Nordisk Investigational Site

Gdansk, , Poland

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Novo Nordisk Investigational Site

Krakow, , Poland

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Novo Nordisk Investigational Site

Warsaw, , Poland

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Novo Nordisk Investigational Site

Coimbra, , Portugal

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Novo Nordisk Investigational Site

Matosinhos Municipality, , Portugal

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Novo Nordisk Investigational Site

Porto, , Portugal

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Novo Nordisk Investigational Site

Vila Nova de Gaia, , Portugal

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Novo Nordisk Investigational Site

Barcelona, , Spain

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Novo Nordisk Investigational Site

Esplugues Llobregat, , Spain

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Novo Nordisk Investigational Site

Granada, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Málaga, , Spain

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Novo Nordisk Investigational Site

Santiago de Compostela, , Spain

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Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Helsingborg, , Sweden

Site Status

Novo Nordisk Investigational Site

Örebro, , Sweden

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Countries

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Czechia Finland Germany Israel Poland Portugal Spain Sweden

References

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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

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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GHLIQUID-1424

Identifier Type: -

Identifier Source: org_study_id

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