Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-04-30

Brief Summary

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To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

Detailed Description

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Conditions

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Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Blood sample

Intervention Type PROCEDURE

Radiography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Males or females : Chronological age \> or = 15 years and \< or = 20 years for females
* Chronological age \> or = 17 years and \< or = 20 years for males
* GHD of childhood onset treated for at least 2 years
* Last GH injection at least 12 months before baseline visit

Exclusion Criteria

* Turner's syndrome
* Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT \> 2 X ULN

Minimum Eligible Age

15 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Countries

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France

Other Identifiers

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A6281018

Identifier Type: -

Identifier Source: secondary_id

307-MET-9002-016