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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
ClinicalTrials.gov Identifier:
NCT01109017
First received: April 19, 2010
Last updated: March 4, 2013
Last verified: February 2013
History of Changes
  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:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Tsutomu Katakura Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
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: March 4, 2013
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 June 18, 2013