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: August 22, 2014
Last verified: August 2014

April 19, 2010
August 22, 2014
October 2009
December 2014   (final data collection date for primary outcome measure)
Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: after 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01109017 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
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.
Norditropin®
Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
387
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01109017
GH-3811, U1111-1114-6250, JapicCTI-101122
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP