Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD
3 other identifiers
observational
387
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 8, 2015
January 1, 2015
5.2 years
April 19, 2010
January 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
after 5 years
Secondary Outcomes (4)
Number of impaired glucose tolerance events during the study period
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Number of other types of adverse events (AEs) during the study period
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects of insulin-like growth factor-1 (IGF-I) levels
evaluated after 3 months, 6 months, 1 year and between 2-5 years
Study Arms (1)
Norditropin®
Interventions
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 Criteria
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
You may qualify if:
- Severe adult growth hormone deficiency
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Tokyo, 1000005, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 22, 2010
Study Start
October 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 8, 2015
Record last verified: 2015-01