Special Survey for Long Term Application

NCT ID: NCT01516229

Last Updated: 2017-02-27

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

Total Enrollment

395 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-05-01

Study Completion Date

2007-03-31

Brief Summary

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This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions.

Detailed Description

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Conditions

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Genetic Disorder Achondroplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Somatropin

somatropin

Intervention Type DRUG

Prescription of somatropin at the discretion of the physician

Interventions

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somatropin

Prescription of somatropin at the discretion of the physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Achondroplasia without epiphyseal line closure
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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GH-1941

Identifier Type: -

Identifier Source: org_study_id

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