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Revised: March 2001
Jill Osborne

The Interstitial Cystitis Clinical Trials Group
Randomized Clinical Trial #1

The Interstitial Cystitis (IC) Clinical Trials Group seeks patients for a medical study using the oral drugs pentosan polysulfate sodium (Elmiron®) and hydroxyzine hydrochloride (Atarax®). People who have IC and unremitting urinary frequency and pain or discomfort lasting at least 24 weeks may be eligible.

Background

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., M.D., Ph.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."

What is Involved in Trial #1?

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.

The study requires:

• Clinic visits
• Symptom questionnaires
• Medical history and physical exams
• Voiding diaries
• Urine and blood samples

The Future

"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."

To join Trial #1, please contact the medical center in your area:

Maryland
John Warren, M.D., and Toby Chai, M.D.
Susan Keay, M.D., and Richard Marvel, M.D.
University of Maryland, Baltimore
Contact: Linda Horne lhorne@medicine.umaryland.edu
Theresa Jackson tjackson@medicine.umaryland.edu
(410) 706-7560

Massachusetts
Grannum R. Sant, M.D., and T.C. Theoharides, Ph.D., M.D.
Tufts University School of Medicine
New England Medical Center, Boston
Contact: Carolyn Shea-O'Malley, R.N. carolyn.shea@es.nemc.org
Patricia Radgowski patricia.radgowski@es.nemc.org
(617) 636-6317

Michigan
Ananias C. Diokno, M.D., and Kenneth Peters, M.D.
William Beaumont Hospital, Royal Oak
Contact: Eleanor Anton, R.N. eanton@beaumont.edu
Maria Perrini mperrini@beaumont.edu
(248) 551-0885

David Burks, M.D.
Henry Ford Hospital, Detroit
Contact: Michelle Peabody, R.N. mpeabod1@smtpgw.is.hfh.edu
(313) 916-8972
Carolyn McCormack cklautr1@smtpgw.is.hfh.edu
(313) 916-8667

New York
Edward M. Messing, M.D., and Robert Mayer, M.D.
University of Rochester, Rochester
Contact: Martha Smith Lightfoot, N.P. martha_lightfoot@urmc.rochester.edu
(716) 275-0133
Elizabeth Smith betty_smith@urmc.rochester.edu
(716) 275-0989

Oklahoma
Daniel J. Culkin, M.D.
University of Oklahoma, Oklahoma City
Contact: Lynda Kelsey, R.N., M.S.
Contact: Karen Mataranglo, R.N., B.S.N
(800)947-6472
(405) 271-6900

Pennsylvania
Alan J. Wein, M.D., and Eric Rovner, M.D.
University of Pennsylvania, Philadelphia
Contact: Marilou Foy, R.N., C.C.R.C.
(215) 349-5874

Kristine E. Whitmore, M.D.
Graduate Hospital, Philadelphia
Contact: Marilou Foy, R.N., C.C.R.C.
(215) 349-5874

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Chairman of the Steering Committee:
Harris Foster, Yale University