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

NCT00519558

GHLIQUID-1518

JapicCTI-R070007 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind