Growth Retardation In Children With Special Pathological Conditions Or Disease

NCT ID: NCT00163215

Last Updated: 2012-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-10-31

Brief Summary

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To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Detailed Description

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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

Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years

Interventions

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Somatropin

Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Bone age \< 13 years for a boy and \< 11 years for a girl
* Naive child: Measured Height \< -2.5 SD for CA
* Child currently treated by GH

Exclusion Criteria

* Idiopathic short stature
* Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis
Minimum Eligible Age

11 Years

Maximum Eligible Age

13 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

Annemasse, , France

Site Status

Pfizer Investigational Site

Besançon, , France

Site Status

Pfizer Investigational Site

Bordeaux, , France

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Pfizer Investigational Site

Bordeaux, , France

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Pfizer Investigational Site

Bron, , France

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Pfizer Investigational Site

Dijon, , France

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Pfizer Investigational Site

Grenoble, , France

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Pfizer Investigational Site

Lorient, , France

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Pfizer Investigational Site

Lyon, , France

Site Status

Pfizer Investigational Site

Marseille, , France

Site Status

Pfizer Investigational Site

Montpellier, , France

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Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Pringy, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Pfizer Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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A6281269

Identifier Type: -

Identifier Source: org_study_id