We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01109017
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : January 8, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somatropin

Study Design

Study Type : Observational
Actual Enrollment : 387 participants
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
Study Start Date : October 2009
Primary Completion Date : December 2014
Study Completion Date : December 2014

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: after 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109017

Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01109017     History of Changes
Other Study ID Numbers: GH-3811
U1111-1114-6250 ( Other Identifier: WHO )
JapicCTI-101122 ( Registry Identifier: JAPIC )
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases