Status:

COMPLETED

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Growth Hormone Disorder

Adult Growth Hormone Deficiency

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficie...

Eligibility Criteria

Inclusion

  • Subjects who completed GHLiquid-1518.
  • If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be 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

  • Subject with a history of acromegaly.
  • Subject with diabetes mellitus.
  • Subject suffering from malignancy.
  • Several medical conditions

Key Trial Info

Start Date :

December 6 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 28 2005

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT00184743

Start Date

December 6 2003

End Date

December 28 2005

Last Update

February 28 2017

Active Locations (1)

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1

Novo Nordisk Investigational Site

Tokyo, Japan, 1000005