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Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00570011
First Posted: December 10, 2007
Last Update Posted: December 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Naples
University of Padua
University of Milan
University of Pisa
Information provided by:
Eli Lilly and Company
December 7, 2007
December 10, 2007
December 11, 2007
June 1997
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00570011 on ClinicalTrials.gov Archive Site
Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients
Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Growth Hormone Deficiency
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: Somatropin
  • Experimental: 2
    Intervention: Drug: Somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
December 1998
Not Provided

Inclusion Criteria:

Patients may be included in the study only if they meet all of the following criteria:

  1. 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,
  2. Adult males and females with GHD either idiopathic or secondary to pituitary disease arising in childhood.
  3. 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.
  4. Receiving replacement for other deficient hormones for at least 3 months prior to the start of the study, where necessary.
  5. Have given informed consent.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

  1. Patients with clinically significant pulmonary, cardiac, hepatic, renal or neuromuscular disease or with chromosomal or genetic malformation syndromes.
  2. Patients who have any evidence of an active tumorous process. Intercranial lesions must be inactive and any antitumour therapy must be complete.
  3. Pregnant women and lactating females or women who decide to become pregnant during the study and who are not taking adequate contraceptives.
  4. Patients thought unlikely to comply with the protocol.
  5. Patients taking an investigational drug in the previous month.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00570011
822
B9R-EW-GDED
Yes
Not Provided
Not Provided
Not Provided
Eli Lilly and Company
  • University of Naples
  • University of Padua
  • University of Milan
  • University of Pisa
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
Eli Lilly and Company
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP