Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

NCT ID: NCT01897766

Last Updated: 2023-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

482 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-05

Study Completion Date

2017-06-07

Brief Summary

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The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

Detailed Description

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All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions

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Small for Gestational Age (SGA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Somatropin

Patients administered Somatropin.

Somatropin

Intervention Type DRUG

0.23 mg to 0.48 mg/kg/week

Interventions

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Somatropin

0.23 mg to 0.48 mg/kg/week

Intervention Type DRUG

Other Intervention Names

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Genotropin

Eligibility Criteria

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Inclusion Criteria

* A patient who was administered Somatropin (Genotropin).

Exclusion Criteria

* N/A.
Minimum Eligible Age

2 Years

Maximum Eligible Age

20 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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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A6281314

Identifier Type: -

Identifier Source: org_study_id

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