Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 5, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00191360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maintenance of efficacy of growth hormone replacement, measured by lean body mass, which is achieved in the previous trial in adult patients wtih growth hormone deficiency

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

Official Title ^ICMJE

Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency

Brief Summary

To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Adult Growth Hormone Deficiency

Intervention ^ICMJE

Drug: Somatropin

Study Arms / Comparison Groups

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Having completed the preceding long-term study of growth hormone replacement in adult patients diagnosed with growth hormone deficiency.
Other pituitary hormone deficiencies being replaced if appropriate

Exclusion Criteria:

With severe impairments of cardiac, pulmonary, renal or hepatic functions
With severe psychological disorders
With malignant cancer
With hypertension uncontrolled
With diabetes mellitus

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00191360

Responsible Party

Study ID Numbers ^ICMJE

6018, B9R-JE-K03A

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

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

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP