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Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

NCT ID: NCT01605331

Last Updated: 2012-10-05

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

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-09-30

Brief Summary

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As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

Detailed Description

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Conditions

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Growth Hormone Deficiency

Keywords

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Adults GH deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sustained-release recombinant human GH (SR-rhGH)

12-week subcutaneous administration, 2mg/week

Group Type EXPERIMENTAL

sustained-release recombinant human GH (SR-rhGH)

Intervention Type DRUG

Interventions

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sustained-release recombinant human GH (SR-rhGH)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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LG-SHCL007

Identifier Type: -

Identifier Source: org_study_id