Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

November 19, 2009

Start Date ^ICMJE

September 2000

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Growth velocity; Number of cm/year [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The main efficacy criteria assess the effects on linear growth of Genotonorm

Change History

Complete list of historical versions of study NCT00174187 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

IGF-1: Insulinlike growth factor-1 [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
Evolution of bone metabolism by absorptiometry: Radiological test [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]
Evolution of body composition by DEXA: Dual X-ray absorptiometry [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

The other efficacy evaluated criteria are the effect of Genotonorm on bone metabolism and body composition. The absorptiometry will evaluate the bone mineralisation and the body composition (lean mass, fat mass) at the inclusion visit and every year duri

Descriptive Information

Brief Title ^ICMJE

Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

Official Title ^ICMJE

Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Brief Summary

To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
To assess the effect of a long term treatment with Genotonorm on bone mineralisation
To assess the effect of a long term treatment with Genotonorm on body composition

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Endocrine System Diseases

Intervention ^ICMJE

Drug: Somatropin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children with juvenile arthritis or nephrotic syndrome
Before or during puberty

Exclusion Criteria:

Diabetes Type 1 and 2
Endocrine disease, except well substituted hypothyroidism

Gender

Both

Ages

11 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00174187

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

307-MET-9002-0009, A6281016

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP