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

NCT ID: NCT00570011

Last Updated: 2007-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-06-30
• Study Completion Date: 1998-12-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Somatropin

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

Somatropin

Intervention Type: DRUG

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

Interventions

Somatropin

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

LLY137998; LLY137998

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Naples

OTHER

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

University of Pisa

OTHER

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

B9R-EW-GDED

Identifier Type: -

Identifier Source: secondary_id

822

Identifier Type: -

Identifier Source: org_study_id