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

NCT00570011 | Completed Phase 3 DMC

• 2 other identifiers: 822B9R-EW-GDED
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2

  6 months

Study Arms (2)

1

EXPERIMENTAL

Drug: Somatropin

2

EXPERIMENTAL

Drug: Somatropin

Interventions

Somatropin DRUG

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

Also known as: LLY137998

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be included in the study only if they meet all of the following criteria:
• 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,
• Adult males and females with GHD either idiopathic or secondary to pituitary disease arising in childhood.
• 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.
• Receiving replacement for other deficient hormones for at least 3 months prior to the start of the study, where necessary.
• Have given informed consent.

You may not qualify if:

• Patients will be excluded from the study for any of the following reasons:
• Patients with clinically significant pulmonary, cardiac, hepatic, renal or neuromuscular disease or with chromosomal or genetic malformation syndromes.
• Patients who have any evidence of an active tumorous process. Intercranial lesions must be inactive and any antitumour therapy must be complete.
• Pregnant women and lactating females or women who decide to become pregnant during the study and who are not taking adequate contraceptives.
• Patients thought unlikely to comply with the protocol.
• Patients taking an investigational drug in the previous month.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• University of Naples: collaborator
• University of Padova: collaborator
• University of Milan: collaborator
• University of Pisa: collaborator

Study Sites (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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: June 1, 1997
• Study Completion: December 1, 1998
• Last Updated: December 11, 2007

Record last verified: 2007-12

Locations

US (1)