A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Injuries; Growth Hormone Deficiency Dwarfism
Intervention: somatropin (Genetic)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baselineNumber of patients with abnormal GH stimulation tests
Secondary outcome: Change from baseline in waist circumferenceAge and gender specific optimal doses of GH replacement Change in Quality of Life-Adult Growth Hormone Deficiency Assessment Assessment of adverse events 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 Change from baseline in Glasgow Outcome Score Change in Quality of Life-Mini-Mental scores
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Pittsburgh, Pennsylvania 15212, United States
Pfizer Investigational Site, El Paso, Texas 79925, United States
Pfizer Investigational Site, Salt Lake City, Utah 84102, United States
Pfizer Investigational Site, Federal Way, Washington 98003, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2002
Last updated: March 27, 2008
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