Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

August 4, 2008 updated by: Pfizer

Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

To assess the effect of long-term treatment by Genotonorm on linear growth

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

14

Phase

  • Phase 3

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

  • France
      • Paris, France
        • Pfizer Investigational Site

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

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
  • All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

  • Endocrine disease, except well substituted hypothyroidism
  • Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

Collaborators and Investigators

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

Sponsor

Pfizer

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.

General Publications

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

February 1, 1997

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 4, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-8123-018
  • A6281217

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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