Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury. - Tabular View

Tracking Information

First Received Date ^ICMJE

February 5, 2007

Last Updated Date

May 15, 2007

Start Date ^ICMJE

April 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00432263 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular

Original Secondary Outcome Measures ^ICMJE

Change CogState™ at Week 12, 24, 60 and 72.
Change in lean body mass and fat mass at Week 36 and 72.
Change in the Extended Glasgow Outcome Scale at week 36 and 72.
Change in quality of life at week 24, 36, 60 and 72.
Summary of change in cardiovascular risk parameters throughout the study and
Summary of change in weight and waist circumference.

Descriptive Information

Brief Title ^ICMJE

Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

Official Title ^ICMJE

Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury

Brief Summary

To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Brain Injuries

Intervention ^ICMJE

Drug: Genotropin (PN-180,307) 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

Withdrawn

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have had a previous traumatic brain injury (more than 1 year and less than 5 years) prior to the screening visit.
Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

Exclusion Criteria:

Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00432263

Responsible Party

Study ID Numbers ^ICMJE

A6281274

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2007

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