Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

NCT ID: NCT00174278

Last Updated: 2008-08-05

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Study Completion Date

2006-10-31

Brief Summary

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To assess the effect of long-term treatment by Genotonorm on linear growth

Detailed Description

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Conditions

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Growth Hormone Deficiency Growth Retardation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Somatropin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
* All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria

* Endocrine disease, except well substituted hypothyroidism
* Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Paris, , France

Site Status

Countries

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France

References

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David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

Reference Type DERIVED
PMID: 29029101 (View on PubMed)

Related Links

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Other Identifiers

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A6281217

Identifier Type: -

Identifier Source: secondary_id

96-8123-018

Identifier Type: -

Identifier Source: org_study_id

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