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

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).

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

sustained-release recombinant human GH (SR-rhGH)

Drug

Primary outcomes

Safety

Time frame: 12 weeks

Adverse event

Secondary outcomes

Efficacy

Time frame: 12 weeks

QoL-AGHDA

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: May 24, 2012
Registry last updated: Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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