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."

IC Clinical Trials Group Centers

CALIFORNIA, Stanford
Stanford University Medical Center
Christopher K. Payne, M.D.
Kathryn Azevedo, Ph.D.
Gilbert Rigaud, M.D.
Debra Clay, R.N., B.S.N.
(650) 724-1753

CANADA, Kingston, Ontario
Queen's University
Alvaro Morales, M.D.
J. Curtis Nickel, M.D.
Joe Downey, B.Sc., M.Sc.
Laurel Emerson, R.N.
(613) 548-6033

MARYLAND, Baltimore
University of Maryland
Toby Chai, M.D.
Susan Keay, M.D.
Richard Marvel, M.D.
John Warren, M.D.
Linda Horne
Theresa Jackson
(410) 706-7560

MASSACHUSETTS, Boston
New England Medical Center
Erol Onel, M.D.
Grannum R. Sant, M.D.
T.C. Theoharides, Ph.D., M.D.
Patricia Radgowski
Carolyn Shea-O'Malley, R.N.
(617) 636-6317

MICHIGAN, Royal Oak
William Beaumont Hospital
Ananias C. Diokno, M.D.
Kenneth Peters, M.D.
Eleanor Anton, R.N.
Loni Lampkins
(248) 551-0885

MICHIGAN, Detroit
Henry Ford Hospital
David Burks, M.D.
Rifaat Dagher, M.D.
Michelle Peabody, R.N.
Jill Sullivan, R.N., B.S.N.
(313) 916-8972

NEW YORK, Rochester
University of Rochester
Robert Mayer, M.D.
Edward M. Messing, M.D.
Kay Rust, R.N., M.S.N., F.N.P.
Elizabeth Smith, B.S.
(716) 275-0133

OKLAHOMA, Oklahoma City
University of Oklahoma
Daniel J. Culkin, M.D.
James F. Donovan Jr., M.D.
Lynda Kelsey, R.N., M.S.
Karen Mataranglo, R.N.
(405) 271-6900

PENNSYLVANIA, Philadelphia
University of Pennsylvania
George W. Drach, M.D.
Philip Hanno, M.D.
Eric Rovner, M.D.
Alan J. Wein, M.D.
Marilou Foy, R.N.
Gloria McNamara, R.N
(215) 349-5874

Data Coordinating Center, Philadelphia
University of Pennsylvania
J. Richard Landis, Ph.D.
Kathleen J. Propert, ScD