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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
  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, and United Kingdom


Condition Phase
Growth Hormone Disorders
 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Somatropin
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 ]

Enrollment: 546
Study Start Date: June 2006
Study Completion Date: December 2011
  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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455884

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

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00455884     History of Changes
Other Study ID Numbers: 2-79-58035-006
Study First Received: April 3, 2007
Last Updated: April 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
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

ClinicalTrials.gov processed this record on May 21, 2013