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

This study has been completed.
Sponsor:
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
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 23, 2014