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Sponsors and Collaborators: |
LG Life Sciences BioPartners GmbH |
Information provided by: | LG Life Sciences |
ClinicalTrials.gov Identifier: | NCT00294619 |
The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.
Condition | Intervention | Phase |
Pituitary Disorders Adult Growth Hormone Deficiency |
Drug: growth hormone |
Phase III |
MedlinePlus related topics: | Pituitary Disorders |
Drug Information available for: | Somatotropin Somatropin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency. |
Estimated Enrollment: | 150 |
Study Start Date: | February 2006 |
Arms | Assigned Interventions |
1: Experimental | Drug: growth hormone |
2: Placebo Comparator | Drug: growth hormone |
Ages Eligible for Study: | 23 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | LG Life Sciences ( Songmi Lee/Clinical Research Manager ) |
Study ID Numbers: | BPLG-005 |
First Received: | February 20, 2006 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00294619 |
Health Authority: | United States: Food and Drug Administration |
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