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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:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Somatropin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients
Study Start Date : June 1997
Study Completion Date : December 1998


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2 [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00570011     History of Changes
Other Study ID Numbers: 822
B9R-EW-GDED
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: December 11, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Dwarfism, Pituitary
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
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs