Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01109017
First received: April 19, 2010
Last updated: June 4, 2014
Last verified: January 2014
  Purpose

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.


Condition Intervention
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: after 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of impaired glucose tolerance events during the study period [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: Yes ]
  • Number of other types of adverse events (AEs) during the study period [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: Yes ]
  • Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: No ]
  • Effects of insulin-like growth factor-1 (IGF-I) levels [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: No ]

Enrollment: 387
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Norditropin® Drug: somatropin
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.

  Eligibility

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

Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study

Criteria

Inclusion Criteria:

  • Severe adult growth hormone deficiency

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Previous participation in the study
  • Diabetes Mellitus
  • Presence of malignant tumor(s)
  • Pregnant or likely to get pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109017

Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tsutomu Katakura Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01109017     History of Changes
Other Study ID Numbers: GH-3811, U1111-1114-6250, JapicCTI-101122
Study First Received: April 19, 2010
Last Updated: June 4, 2014
Health Authority: Japan: Pharmaceuticals and medical devices agency (PMDA)

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 July 26, 2014