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

Phase 4

Terminated

• Conditions: Brain Injuries; Growth Hormone Deficiency Dwarfism
• Interventions: Genetic: somatropin

• Registration Number: NCT00638053
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2002-11
• Study Completion: 2003-11
• Status Verified: 2008-03
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-18
• Last Update Submitted: 2008-03-27
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	somatropin	-

Primary Outcome Measures

Name	Time	Method
Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline	Months 1 thru 11
Number of patients with abnormal GH stimulation tests	Baseline

Secondary Outcome Measures

Name	Time	Method
Change from baseline in waist circumference	Month 12
Age and gender specific optimal doses of GH replacement	Months 1 thru 11
Change in Quality of Life-Adult Growth Hormone Deficiency Assessment	Months 1 thru 12
Assessment of adverse events	Months 1 thru 12
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	Baseline
Change from baseline in Glasgow Outcome Score	Month 12
Change in Quality of Life-Mini-Mental scores	Months 1 thru 12

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Federal Way, Washington, United States