Growth Retardation In Children With Special Pathological Conditions Or Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

October 13, 2009

Start Date ^ICMJE

March 2005

Current Primary Outcome Measures ^ICMJE

The main criterion of efficacy is the 12-month Growth rate in SD for chronological age (CA) the 3rd year after Visit 2. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The main criterion of efficacy is the 12-month Growth rate in SD for chronological age (CA) the 3rd year after Visit 2.

Change History

Complete list of historical versions of study NCT00163215 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To estimate the evolution of height under Growth Hormone (GH) treatment after 1, 2 and 3 years [ Time Frame: Month 18 and Month 36 ] [ Designated as safety issue: No ]
To estimate the growth rate 1 and 2 years after inclusion in the study [ Time Frame: Month 12 and Month 24 ] [ Designated as safety issue: No ]
To confirm the good clinical and biological safety of GH treatment in such children [ Time Frame: Baseline, Month 12, Month 18, Month 24, Month 36 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Growth Retardation In Children With Special Pathological Conditions Or Disease

Official Title ^ICMJE

Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.

Brief Summary

To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Bone age < 13 years for a boy and < 11 years for a girl
Naive child: Measured Height < -2.5 SD for CA
Child currently treated by GH

Exclusion Criteria:

Idiopathic short stature
Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

Gender

Both

Ages

11 Years to 13 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00163215

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A6281269

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2009

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