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

Adult Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109017
• Other study ID #: GH-3811
• Secondary ID: U1111-1114-6250J
• Status: Completed
• Phase: N/A
• First received: April 19, 2010
• Last updated: January 7, 2015
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of suspected serious adverse drug reactions (SADRs) during the study period		after 5 years	Yes
Secondary	Number of impaired glucose tolerance events during the study period		evaluated after 3 months, 6 months, 1 year and between 2-5 years	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Effects of insulin-like growth factor-1 (IGF-I) levels		evaluated after 3 months, 6 months, 1 year and between 2-5 years	No

External Links

•   Clinical Trials at Novo Nordisk