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

April 3, 2007
April 3, 2012
June 2006
Not Provided
Incidence of serious adverse events [ Time Frame: when reported ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00455884 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Growth Hormone Disorders
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
546
December 2011
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Active neoplasia
  • Pregnancy
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00455884
2-79-58035-006
No
Ipsen
Ipsen
Not Provided
Study Director: Pascale Dutailly, MD Ipsen
Ipsen
April 2012

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