New Clinical Trial Announced!

Here's more information I got on that important trial from the U.S. Department of Health and Human Services:

1. CLINICAL TRIAL TESTS BCG FOR INTERSTITIAL CYSTITIS

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Date: Fri, 26 Oct 2001 09:18:47 -0400
From: "NIH OLIB (OD)" <[email protected]>
Subject: CLINICAL TRIAL TESTS BCG FOR INTERSTITIAL CYSTITIS

NATIONAL INSTITUTES OF HEALTH

National Institute of Diabetes and Digestive and Kidney
Diseases

NIH NEWS ADVISORY

FOR IMMEDIATE RELEASE
October 25, 2001

Contact: Mary Harris
301-496-3583

CLINICAL TRIAL TESTS BCG FOR INTERSTITIAL CYSTITIS

Ten centers in the United States and Canada seek 260
patients to try a promising therapy for interstitial
cystitis (IC), a chronic and painful bladder condition that
mostly targets women.

The IC Clinical Trials Group study funded by the National
Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) will test whether the bacterium Bacillus Calmette-
Guérin (BCG) will relieve the pelvic pain and frequent
urination that are hallmarks of IC. Participants will be
randomly assigned to have either a BCG or saline solution
temporarily placed in the bladder during each of six clinic
visits. Neither doctors nor patients will know who
received the BCG until the study's end. Patients whose
symptoms are not relieved by the initial series will be
openly offered BCG.

BCG is a vaccine for tuberculosis and a treatment for
superficial bladder cancer. Exactly how BCG works in the
bladder is still a mystery, but research suggests it may
stimulate a protective immune response and downplay a
harmful one in the IC bladder. If BCG fulfills the promise
of earlier studies, it could profoundly alter disease
management and patients' quality of life, which has been
described as worse than being on kidney dialysis. Symptoms
are so severe that only about 50 percent of an estimated 1
million IC patients are able to work full time. The
disorder accounts for $1.7 billion in lost wages and
medical expenses. About a quarter of patients are younger
than 30 years.

Anyone interested in joining the trial may contact study
coordinators on the enclosed list. Clinics are in
Baltimore; Boston; Detroit and Royal Oak, Michigan;
Kingston, Ontario, Canada; Oklahoma City; Philadelphia;
Rochester, New York; and Stanford, California.
Coordinators want to enroll patients now but will continue
recruiting through September 2002, unless a quorum is
reached earlier. Study results are expected to be
available March 2004.

Interstitial Cystitis Clinical Trial: Centers and
Investigators http://www.niddk.nih.gov/welcome/releases/10-25-01
centers.htm

To learn more about IC, visit http://www.niddk.nih.gov/health/urol...s/cystitis/cys
titis.htm or call the National Kidney and Urologic Diseases
Information Clearinghouse at (800) 891-5390.

BCG and saline solutions for this study are provided by
Organon Teknika, Durham, NC.

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