A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders

NCT ID: NCT00455728

Last Updated: 2019-01-07

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

3690 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2016-12-31

Brief Summary

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This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.

Detailed Description

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The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.

Conditions

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Growth Hormone Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children of either sex who are treated with NutropinAq® for the treatment of growth failure
* Patients who are willing to comply with follow-up appointments throughout study participation
* Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable

Exclusion Criteria

* Patients not treated with NutropinAq®
* Patients with closed epiphyses
* Patients with active neoplasia
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Ipsen Central Contact

Slough, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Coutant R, Bosch Munoz J, Dumitrescu CP, Schnabel D, Sert C, Perrot V, Dattani M. Effectiveness and Overall Safety of NutropinAq(R) for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq(R) European Registry (iNCGS). Front Endocrinol (Lausanne). 2021 May 25;12:676083. doi: 10.3389/fendo.2021.676083. eCollection 2021.

Reference Type DERIVED
PMID: 34113318 (View on PubMed)

Other Identifiers

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EUPAS7948

Identifier Type: REGISTRY

Identifier Source: secondary_id

2-79-58035-005

Identifier Type: -

Identifier Source: org_study_id

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