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  • Green15
    replied
    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

    ----------------------------------------------------------------------

    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.

    ##

    To subscribe (or unsubscribe) from this list, go to http://list.nih.gov/cgi-bin/wa?SUBED1=hhspress&A=1

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  • icnmgrjill
    started a topic New Clinical Trial Announced!

    New Clinical Trial Announced!

    2001 Interstitial Cystitis Clinical Trials Group Begins New National IC Study on BCG

    Eight research centers in the USA and Canada are beiginning the next major IC clinical trial, this time testing the use of BCG (Bacillus Calmette Guerin) for IC. Review the clinical research center sites & contact information, as well as several statements released by individual research centers.

    Read more about it at: http://www.ic-network.com/md/
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