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Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients
This study has been completed.
Sponsors and Collaborators: Eli Lilly and Company
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

Genetics Home Reference related topics: pseudoachondroplasia
Drug Information available for: Somatotropin Somatropin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients

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
1: Experimental 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.
2: Experimental 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.

  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:

  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.
  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

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Study ID Numbers: 822, B9R-EW-GDED
Study First Received: December 7, 2007
Last Updated: December 10, 2007
ClinicalTrials.gov Identifier: NCT00570011  
Health Authority: Italy: Ministry of Health

Study placed in the following topic categories:
Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009