Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome (NordiPAD)

July 2, 2015 updated by: Novo Nordisk A/S

A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.

This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2016

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

Non-Probability Sample

Study Population

Patients from normal practice who have been deemed appropriate to receive somatropin ( Norditropin®) as part of routine out-patient care by the prescribing physician.

Description

Inclusion Criteria:

  • Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed

Exclusion Criteria:

  • Diabetic
  • Patients with malignant tumors
  • Women who are either pregnant or likely to be pregnant
  • Known or suspected allergy to study product(s) or related products

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Somatropin
Drug: somatropin
Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in height
Time Frame: Week 0, Month 36, final height is reached
Week 0, Month 36, final height is reached
Incidence of adverse reactions (ADRs)
Time Frame: 36 months, accumulation of study period
36 months, accumulation of study period

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

May 1, 2005

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Estimate)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-3910

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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