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Sponsors and Collaborators: |
Eli Lilly and Company University of Naples University of Padua University of Milan University of Pisa |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00570011 |
An international study in which patients with GHD were randomized to receive somatropin at a dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.
Condition | Intervention | Phase |
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Growth Hormone Deficiency |
Drug: Somatropin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients |
Enrollment: | 112 |
Study Start Date: | June 1997 |
Study Completion Date: | December 1998 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Somatropin
3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.
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2: Experimental |
Drug: Somatropin
6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients may be included in the study only if they meet all of the following criteria:
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
United States, Indiana | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Indianapolis, Indiana, United States |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 822, B9R-EW-GDED |
Study First Received: | December 7, 2007 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00570011 |
Health Authority: | Italy: Ministry of Health |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Pituitary Diseases Central Nervous System Diseases Endocrine System Diseases Dwarfism, Pituitary |
Brain Diseases Bone Diseases Growth hormone deficiency Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental Endocrinopathy |
Nervous System Diseases |