Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.
This study has been withdrawn prior to enrollment.
Information provided by:
First received: February 5, 2007
Last updated: May 15, 2007
Last verified: May 2007
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury|
Resource links provided by NLM:
Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency Meier-Gorlin syndrome metatropic dysplasia pseudoachondroplasiaU.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
Secondary Outcome Measures:
- 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
|Study Start Date:||April 2007|
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