Special Survey for Long Term Application

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ClinicalTrials.gov Identifier: NCT01516229

Recruitment Status : Completed

First Posted : January 24, 2012

Last Update Posted : February 27, 2017

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

Tracking Information

First Submitted Date

January 19, 2012

First Posted Date

January 24, 2012

Last Update Posted Date

February 27, 2017

Actual Study Start Date

May 1, 1997

Actual Primary Completion Date

March 31, 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Incidence of adverse drug reactions (ADRs)

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Special Survey for Long Term Application

Official Title

Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application

Brief Summary

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

Not Provided

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients being treated with somatropin for achondroplasia without epiphyseal line closure

Condition

Genetic Disorder
Achondroplasia

Intervention

Drug: somatropin

Prescription of somatropin at the discretion of the physician

Study Groups/Cohorts

Somatropin

Intervention: Drug: somatropin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Actual Enrollment

395

Original Actual Enrollment

Same as current

Actual Study Completion Date

March 31, 2007

Actual Primary Completion Date

March 31, 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Achondroplasia without epiphyseal line closure

Sex/Gender

Sexes Eligible for Study:

All

Ages

1 Year to 15 Years (Child)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Japan

Removed Location Countries

Administrative Information

NCT Number

NCT01516229

Other Study ID Numbers

GH-1941

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Novo Nordisk A/S

Study Sponsor

Novo Nordisk A/S

Collaborators

Not Provided

Investigators

Study Director:

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S

PRS Account

Novo Nordisk A/S

Verification Date

February 2017

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