A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury - Tabular View

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

March 27, 2008

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline [ Time Frame: Months 1 thru 11 ] [ Designated as safety issue: No ]
Number of patients with abnormal GH stimulation tests [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in waist circumference [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Age and gender specific optimal doses of GH replacement [ Time Frame: Months 1 thru 11 ] [ Designated as safety issue: No ]
Change in Quality of Life-Adult Growth Hormone Deficiency Assessment [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]
Assessment of adverse events [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]
Serum prolactin, thyroid stimulating hormone, free thyroxine serum, cortisol, adrenocorticotropic hormone, luteinizing hormone, follicle stimulating hormone, estradiol, and testosterone to assess degree of other anterior pituitary hormone deficiencies [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Change from baseline in Glasgow Outcome Score [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Change in Quality of Life-Mini-Mental scores [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury

Official Title ^ICMJE

Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury

Brief Summary

The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury

Detailed Description

The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Brain Injuries
Growth Hormone Deficiency Dwarfism

Intervention ^ICMJE

Genetic: 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

Terminated

Estimated Enrollment ^ICMJE

100

Completion Date

November 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Documented GHD
Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)

Exclusion Criteria:

Active systemic malignancy or active intracranial tumor
Growth hormone replacement therapy in the last 12 months
History of dementia unrelated to traumatic brain injury

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00638053

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

GENGHD-0018-078

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

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