A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency

This study is currently recruiting participants.

Verified by Ipsen, April 2009

First Received: April 3, 2007 Last Updated: April 23, 2009 History of Changes

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00455884

Purpose

This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, Spain, United Kingdom and Austria

Condition	Phase
Growth Hormone Disorders	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Incidence of serious adverse events [ Time Frame: when reported ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death [ Time Frame: when reported ] [ Designated as safety issue: Yes ]
Incidence of intercurrent cardiovascular events [ Time Frame: when reported ] [ Designated as safety issue: Yes ]
Incidence of fractures [ Time Frame: when reported ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients treated with NutropinAq in the specialised adult endocrinology centres in Germany, Austria, Italy, UK and Spain.

Criteria

Inclusion Criteria:

Patients with Growth Hormone Deficiency
Patients treated with NutropinAq®
Patients having completed growth (fused epiphyses)

Exclusion Criteria:

Active neoplasia
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455884

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

No publications provided

Responsible Party:	Ipsen group ( Hugues Berard MD )
Study ID Numbers:	2-79-58035-006
Study First Received:	April 3, 2007
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00455884 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Agency for Health and Food Safety

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Hypopituitary Dwarfism
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary

Brain Diseases
Hormones
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Growth Hormone Deficiency
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases

Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on September 10, 2009