Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

NCT ID: NCT01109017

Last Updated: 2015-01-08

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

387 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-12-31

Brief Summary

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This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.

Detailed Description

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Conditions

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Growth Hormone Disorder Adult Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Norditropin®

somatropin

Intervention Type DRUG

Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.

Interventions

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somatropin

Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe adult growth hormone deficiency

Exclusion Criteria

* Known or suspected allergy to study product(s) or related products
* Previous participation in the study
* Diabetes Mellitus
* Presence of malignant tumor(s)
* Pregnant or likely to get pregnant
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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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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U1111-1114-6250

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-101122

Identifier Type: REGISTRY

Identifier Source: secondary_id

GH-3811

Identifier Type: -

Identifier Source: org_study_id

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