Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients
This study has been completed.
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
First received: December 7, 2007
Last updated: December 10, 2007
Last verified: December 2007
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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 3 |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
Meier-Gorlin syndrome
metatropic dysplasia
pseudoachondroplasia
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA) as a function of changes in insulin levels was investigated. [ Time Frame: 6 months ]
Secondary Outcome Measures:
- Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 [ Time Frame: 6 months ]
| 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 |
Criteria
Inclusion Criteria:
Patients may be included in the study only if they meet all of the following criteria:
- Adult males and females with GHD, arising during adult life from pituitary ablation or failure, onset of GHD have taken place at least 1 year before entering the study, or,
- Adult males and females with GHD either idiopathic or secondary to pituitary disease arising in childhood.
- Demonstrated GHD as documented by a negative response to a standard GH stimulation test within the last 5 years previous year (see Section 3.4.3, part b). Maximal peak must be less than 3.0 ng/ml.
- Receiving replacement for other deficient hormones for at least 3 months prior to the start of the study, where necessary.
- Have given informed consent.
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
- Patients with clinically significant pulmonary, cardiac, hepatic, renal or neuromuscular disease or with chromosomal or genetic malformation syndromes.
- Patients who have any evidence of an active tumorous process. Intercranial lesions must be inactive and any antitumour therapy must be complete.
- Pregnant women and lactating females or women who decide to become pregnant during the study and who are not taking adequate contraceptives.
- Patients thought unlikely to comply with the protocol.
- Patients taking an investigational drug in the previous month.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570011
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570011
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 | |
Sponsors and Collaborators
Eli Lilly and Company
University of Naples
University of Padua
University of Milan
University of Pisa
Investigators
| 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
Additional Information:
No publications provided
| 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 |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism |
Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases |
ClinicalTrials.gov processed this record on March 03, 2015