Safety and Efficacy of Long-term Somatropin Treatment in Children

NCT ID: NCT01543867

Last Updated: 2015-03-30

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

Total Enrollment

5442 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2011-12-31

Brief Summary

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This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

Detailed Description

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Conditions

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Growth Hormone Disorder Growth Hormone Deficiency in Children Foetal Growth Problem Small for Gestational Age Genetic Disorder Turner Syndrome Growth Disorder Idiopathic Short Stature

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Users of somatropin

somatropin

Intervention Type DRUG

Prescribed at the discretion of the treating physician according to product labelling

Interventions

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somatropin

Prescribed at the discretion of the treating physician according to product labelling

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* In need of somatropin or current user
Maximum Eligible Age

18 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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Mainz, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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GH-1930

Identifier Type: -

Identifier Source: org_study_id

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