Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-03-31

Study Completion Date

2005-02-28

Brief Summary

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The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

Detailed Description

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Conditions

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Growth Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Genotropin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Birth length below -2 SD
* Height at start below - 2 Sd

Exclusion Criteria

* Any endocrine or chronic disease
* Any known syndrome with short stature

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

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A6281048

Identifier Type: -

Identifier Source: secondary_id

89-041