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| Sponsor: | Eli Lilly and Company |
|---|---|
| Collaborators: |
University of Naples University of Padua University of Milan University of Pisa |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00570011 |
Purpose
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 |
|---|---|---|
|
Growth Hormone Deficiency |
Drug: Somatropin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
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.
Other Name: LLY137998
|
| Experimental: 2 |
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.
Other Name: LLY137998
|
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00570011 History of Changes |
| Other Study ID Numbers: | 822, B9R-EW-GDED |
| Study First Received: | December 7, 2007 |
| Last Updated: | December 10, 2007 |
| Health Authority: | Italy: Ministry of Health |
|
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |