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

January 7, 2015 updated by: Novo Nordisk A/S

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

387

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Norditropin®
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Time Frame: after 5 years
after 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of impaired glucose tolerance events during the study period
Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Number of other types of adverse events (AEs) during the study period
Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects of insulin-like growth factor-1 (IGF-I) levels
Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
evaluated after 3 months, 6 months, 1 year and between 2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-3811
  • U1111-1114-6250 (Other Identifier: WHO)
  • JapicCTI-101122 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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