A Post Marketing Surveillance Program for NutropinAq® in Pediatric Growth Disorders - Full Text View

A Post Marketing Surveillance Program for NutropinAq® in Pediatric Growth Disorders

This study is currently recruiting participants.
Verified by Ipsen, October 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00455728

Purpose

This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in France, Germany, Italy, Spain, United Kingdom and Austria

Condition	Phase
Growth Hormone Disorders	Phase IV

MedlinePlus related topics:

Growth Disorders

Drug Information available for:

Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]

Further study details as provided by Ipsen:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2099

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children treated with NutropinAq in the specialised paediatric endocrinology centres in France, Germany, Spain, Italy and UK.

Criteria

Inclusion Criteria:

Children of either sex who are treated with NutropinAq® for the treatment of growth failure
Patients who are willing to keep follow up appointments throughout study participation

Exclusion Criteria:

Patients not treated with NutropinAq®
Patients with closed epiphyses
Patients with active neoplasia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455728

Contacts


Contact: Ipsen Recruitment Enquiries		clinical.trials@ipsen.com

Locations


United Kingdom, Berkshire
	Ipsen Central Contact	Recruiting
	Slough, Berkshire, United Kingdom, SL1 3XE
	Contact clinical.trials@ipsen.com

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	Pascale Dutailly, MD	Ipsen

More Information

Responsible Party:	Ipsen Group ( Hugues Berard MD )
Study ID Numbers:	2-79-58035-005
First Received:	April 3, 2007
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00455728
Health Authority:	France: French Data Protection Authority; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Ministry of Health; Austria: Agency for Health and Food Safety; Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Growth Disorders

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 21, 2008