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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT00455884

First received: April 3, 2007

Last updated: April 3, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2007

Last Updated Date

April 3, 2012

Start Date ^ICMJE

June 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00455884 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency

Brief Summary

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, and United Kingdom

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Growth Hormone Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

546

Completion Date

December 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Active neoplasia
Pregnancy

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00455884

Other Study ID Numbers ^ICMJE

2-79-58035-006

Has Data Monitoring Committee

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pascale Dutailly, MD

Ipsen

Information Provided By

Ipsen

Verification Date

April 2012

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

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