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

Phase 3

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Somatropin

• Registration Number: NCT00570011
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-06
• Study Completion: 1998-12
• Status Verified: 2007-12
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Last Update Submitted: 2007-12-10
• Last Update Posted: 2007-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Somatropin	-
2	Somatropin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2	6 months

Trial Locations

Locations (1)

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