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

Growth Hormone Deficiency Clinical Trial

Official title:

Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570011
• Other study ID #: 822
• Secondary ID: B9R-EW-GDED
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2007
• Last updated: December 10, 2007
• Start date: June 1997
• Est. completion date: December 1998

Study information

• Verified date: December 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

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.
• Somatropin
6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
Eli Lilly and Company	University of Milan, University of Naples, University of Padua, University of Pisa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA) as a function of changes in insulin levels was investigated.		6 months
Secondary	Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2		6 months

External Links

•   Lilly Clinical Trial Registry