The University of Nebraska Medical Center is looking for people, ages
19 to 80, who have flu symptoms and would like to participate in a drug
study. A $100 stipend will be paid to participants who successfully complete
the study. All visits, laboratory tests and medication will be free.
UNMC researchers, Jennifer Ekin, M.D., principal investigator of the
study and LeeRoy Meyer, M.D., are involved in testing Neuraminidase Inhibitor,
R0 64-0797, also known as GS4104, an oral drug currently in phase III development
through Roche Laboratories.They are studying the drugs effectiveness in
decreasing the length and severity of influenza in adults.
Flu suffering is caused by virus multiplication. The virus neuraminidase
enzyme allows release of viruses from infected cells and enables further
spreading and infection. GS4104 blocks the enzyme and prevents spread of
the disease to other parts of the body.
We are looking for people who are just starting to have symptoms,
Dr. Ekin said. Flu symptoms include respiratory problems such as nasal
congestion and cough as well as systemic symptoms including chills, fever,
body aches and fatigue.
In an average year, influenza is associated with about 20,000 deaths
nationwide and many more hospitalizations, according to the U.S. Centers
for Disease Control Prevention. The CDC estimates that during most influenza
seasons, about 10 to 20 percent of the population is infected with influenza.
Secondary complications such as bronchitis and sinusitis can develop,
requiring medical attention. Severe complications like pneumonia are particularly
dangerous to the elderly.
The study requires medication twice a day for five days, keep diary
cards and take their temperature daily. Participants will make a total
of five visits to the Durham Outpatient Center located on the UNMC campus
at 45th and Emile Streets. The study is a double-blind study, with some
patients receiving a placebo and others receiving the drug.
Six studies on GS4104 have been done to date with more than 2,500 people,
according to Roche Laboratories. Two studies have already been conducted
with the drug in the U.S., Europe, Canada and China. These studies have
found oral GS4104 to significantly decrease the duration and severity of
acute influenza in adults and worked best if taken early.
The UNMC study is open to normally healthy adults and excludes people
with certain types of conditions or diseases. If you are interested in
participating in the study, call UNMC at (402) 559-7504.
UNMC is the only public academic health science center in the state.
Through its commitment to research, education and patient care, UNMC has
established itself as one of the country’s leading centers for cancer research
and treatment and solid organ transplantation. More than $34 million
in research grants and contracts are awarded to UNMC scientists annually.
In addition, UNMC’s educational programs are responsible for training more
health professionals practicing in Nebraska than any other institution.