The Interstitial Cystitis Clinical Trials Group will use pentosan polysulfate
sodium (Elmiron®) and hydroxyzine hydrochloride (Atarax®) to treat 136
people who have IC and unremitting urinary frequency and pain or
discomfort lasting at least 24 weeks.
Elmiron® and Atarax® were selected first for testing because patients prefer
oral treatments and studies suggest that each drug uniquely targets different
aspects of IC. In some patients, Elmiron® reinforces the bladder lining,
usually a barrier to urine's toxicity. Elmiron® is the only oral drug approved
by the Food and Drug Administration for IC. Atarax® is an antihistamine
that reduces the activity of mast cells, which may cause bladder inflammation
and pain. The two drugs may also work synergistically, leading to quicker,
more potent symptom relief.
"IC leaves many people unable to cope with basic daily functions," says
Leroy M. Nyberg Jr., Ph.D., M.D., director of urology research at the
National Institute of Diabetes and Digestive and Kidney Diseases, which is
funding the clinical trial. "This is the first of a series of rigorous treatment
trials. Our ultimate goal is to be able to recommend to physicians those
therapies most likely to relieve symptoms in subgroups of patients." The
cause of interstitial cystitis is unknown and no one therapy works effectively
in a large number of patients. Often mistaken for a bladder infection, IC may
elude diagnosis for years.
Clinical trial participants will be divided into four groups to receive either (1)
a placebo, (2) Elmiron®, (3) Atarax®, or (4) both active drugs for 6 to 16
months, depending on when they join. At the end of the study, doctors will
compare self-reported symptom improvement between the placebo group
and drug groups.
"If the results are promising, we want to study more patients over a longer
time. This would allow us to gather more solid information about the
therapies and how we can help patients," says Nyberg. "And we are
exploring other possible treatments to evaluate in subsequent trials."
J. Richard Landis, Ph.D., at the University of Pennsylvania School of
Medicine in Philadelphia is coordinating data collection and analysis.
Notes: A fact sheet on IC is at
A list of centers and doctors is attached and at
David Burks, M.D.
Henry Ford Hospital, Detroit
Kristine E. Whitmore, M.D.
Graduate Hospital, Philadelphia
Marilou Foy, R.N., C.C.R.C.