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
metatropic dysplasia
pseudoachondroplasia
MedlinePlus related topics:
Diabetes Medicines
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
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 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 |
ClinicalTrials.gov processed this record on May 19, 2013