Expired Study
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Indianapolis, Indiana


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.


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.


Study is Available At:


Original ID:

822


NCT ID:

NCT00570011


Secondary ID:

B9R-EW-GDED


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

Italy: Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

112


Enrollment Type:

Actual


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:June 1997
Completion Date:December 1998
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 10, 2007
First Received Date:December 7, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Somatropin
Description:3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.
Arm Name:1
Other Name:LLY137998
Intervention Type:Drug
Name:Somatropin
Description:6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.
Arm Name:2
Other Name:LLY137998

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Experimental
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Naples

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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