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Growth Hormone Deficiency in Adults (GHDA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519558
First Posted: August 22, 2007
Last Update Posted: February 28, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).

Condition Intervention Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somatropin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percent change in truncal fat (kg) from baseline [ Time Frame: at 24 weeks (end of treatment) ]

Secondary Outcome Measures:
  • Change in total body fat, total LBM, etc. from baseline to 24 weeks
  • Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
  • IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
  • Adverse events
  • Clinical laboratory tests
  • FPG, insulin, and HbA1c

Enrollment: 121
Actual Study Start Date: May 31, 2003
Study Completion Date: January 24, 2005
Primary Completion Date: January 24, 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with diagnosed GHD
  • If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded
  • Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies

Exclusion Criteria:

  • Subject with a history of acromegaly
  • Subject with diabetes mellitus
  • Subject suffering from malignancy
  • Several medical conditions
  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): NCT00519558


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00519558     History of Changes
Other Study ID Numbers: GHLIQUID-1518
JapicCTI-R070007 ( Registry Identifier: JAPIC )
First Submitted: August 20, 2007
First Posted: August 22, 2007
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs