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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Drug: Somatropin; Drug: Somatropin

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: LLY137998; 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 Names: LLY137998
Experimental: 2	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 Names: LLY137998; 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 Names: LLY137998

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2	6 months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: University of Pisa; University of Padova; University of Milan; University of Naples

Study record dates

Study Major Dates

• Study Start: June 1, 1997
• Study Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: December 7, 2007
• First Submitted That Met QC Criteria: December 7, 2007
• First Posted (Estimate): December 10, 2007

Study Record Updates

• Last Update Posted (Estimate): December 11, 2007
• Last Update Submitted That Met QC Criteria: December 10, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: 822; B9R-EW-GDED