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Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

NCT ID: NCT00174187

Last Updated: 2012-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2011-09-30

Brief Summary

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* To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
* To assess the effect of a long term treatment with Genotonorm on bone mineralisation
* To assess the effect of a long term treatment with Genotonorm on body composition

Detailed Description

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This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Conditions

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Endocrine System Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somatropin

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Interventions

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Somatropin

liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children with juvenile arthritis or nephrotic syndrome
* Before or during puberty

Exclusion Criteria

* Diabetes Type 1 and 2
* Endocrine disease, except well substituted hypothyroidism
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=307-MET-9002-0009&StudyName=Treatment%20with%20Recombinant%20Human%20Growth%20Hormone%20%28GH%29%20in%20Children%20with%20Short%20Stature%20Secondary%20to%20a%20Long%20Term%20Corticoid%20Therap

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6281016

Identifier Type: -

Identifier Source: secondary_id

307-MET-9002-0009

Identifier Type: -

Identifier Source: org_study_id