Growth Hormone Deficiency in Adults (GHDA)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00519558
First received: August 20, 2007
Last updated: June 28, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total body fat, total LBM, etc. from baseline to 24 weeks [ Designated as safety issue: No ]
  • Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) [ Designated as safety issue: No ]
  • IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Designated as safety issue: No ]
  • FPG, insulin, and HbA1c [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519558

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Yoshihisa Ogawa, M.Sc Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00519558     History of Changes
Other Study ID Numbers: GHLIQUID-1518, JapicCTI-R070007
Study First Received: August 20, 2007
Last Updated: June 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 23, 2014