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

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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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA) as a function of changes in insulin levels was investigated.

Secondary Outcome

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

Condition

Growth Hormone Deficiency

Intervention

Somatropin

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

112

Start Date

June 1997

Completion Date

December 1998


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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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), , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00570011

Organization ID

822

Secondary IDs

B9R-EW-GDED


Study Sponsor

Eli Lilly and Company

Collaborators

 University of Naples

Study Sponsor

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


Verification Date

December 2007