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

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ClinicalTrials.gov Identifier: NCT00455884
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

Condition or disease
Growth Hormone Disorders

Study Type : Observational
Actual Enrollment : 546 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency
Study Start Date : June 2006
Actual Study Completion Date : December 2011





Primary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: when reported ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of intercurrent cardiovascular events [ Time Frame: when reported ]
  3. Incidence of fractures [ Time Frame: when reported ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients treated with NutropinAq in the specialised adult endocrinology centres in Germany, Italy, and UK.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Active neoplasia
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455884


Locations
United Kingdom
Ipsen Central Contact
Slough, Berkshire, United Kingdom, SL1 3XE
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Pascale Dutailly, MD Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00455884     History of Changes
Other Study ID Numbers: 2-79-58035-006
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs