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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-06

Study Completion Date

2005-12-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Disorder Adult Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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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.