Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00570011
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : December 11, 2007
Sponsor:
Collaborators:
University of Naples
University of Padua
University of Milan
University of Pisa
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 7, 2007
First Posted Date  ICMJE December 10, 2007
Last Update Posted Date December 11, 2007
Study Start Date  ICMJE June 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00570011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients
Official Title  ICMJE Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Somatropin
  • Experimental: 2
    Intervention: Drug: Somatropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2007)
112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1998
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00570011
Other Study ID Numbers  ICMJE 822
B9R-EW-GDED
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE
  • University of Naples
  • University of Padua
  • University of Milan
  • University of Pisa
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date December 2007

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