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

Phase 4TerminatedNCT00638053

Pfizer100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Brain Injuries Growth Hormone Deficiency Dwarfism

Interventions

somatropinGENETIC

Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (4)

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Pfizer Investigational Site

El Paso, Texas, United States

Pfizer Investigational Site

Salt Lake City, Utah, United States

Pfizer Investigational Site

Federal Way, Washington, United States

Outcomes

Primary Outcomes

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline

Time frame: Months 1 thru 11

Number of patients with abnormal GH stimulation tests

Time frame: Baseline

Secondary Outcomes

Change from baseline in waist circumference

Time frame: Month 12

Age and gender specific optimal doses of GH replacement

Time frame: Months 1 thru 11

Change in Quality of Life-Adult Growth Hormone Deficiency Assessment

Time frame: Months 1 thru 12

Assessment of adverse events

Time frame: 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

Time frame: Baseline

Change from baseline in Glasgow Outcome Score

Time frame: Month 12

Change in Quality of Life-Mini-Mental scores

Time frame: Months 1 thru 12

Data from ClinicalTrials.gov

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