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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184743

JapicCTI-050133 (Registry Identifier)

GHLIQUID-1519

Details and patient eligibility

About

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 Deficiency, comparing two different treatment regiments.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)