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| Sponsor: | LG Life Sciences |
|---|---|
| Collaborator: |
BioPartners GmbH |
| Information provided by: | LG Life Sciences |
| ClinicalTrials.gov Identifier: | NCT00294619 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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: | April 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: growth hormone
subcutaneous injection, once-weekly
|
| Placebo Comparator: 2 |
Drug: growth hormone
subcutaneous injection, once-weekly
|
Eligibility| Ages Eligible for Study: | 23 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Songmi Lee/Clinical Research Manager, LG Life Sciences |
| ClinicalTrials.gov Identifier: | NCT00294619 History of Changes |
| Other Study ID Numbers: | BPLG-005 |
| Study First Received: | February 20, 2006 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Growth hormone deficiency |
|
Dwarfism, Pituitary Pituitary Diseases Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |