Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Last updated: May 27, 2020
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Completed

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Dysmenorrhea (Painful Periods)

Gynecological Infections

Treatment

N/A

Clinical Study ID

NCT00103402
CPCRN2 Afluzosin
RFA-DK-03-004
U01DK065209
  • Ages > 18
  • Male

Study Summary

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has signed and dated the appropriate Informed Consent document.

  • Participant is male.

  • Participant is at least 18 years of age.

  • Participant has had symptoms of discomfort or pain in the pelvic region for at least asix-week interval at the time of presentation.

  • Symptoms bothersome enough to prompt a physician visit have been present for two yearsor less.

Exclusion

Exclusion Criteria:

  • Participant has evidence of facultative Gram negative or enterococcus with a value ofgreater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).

  • Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), orother alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the pasttwo years for any other reason.

  • Participant has a history of prostate, penile, testicular, bladder, or urethral canceror has undergone pelvic radiation, systemic chemotherapy, or intravesicalchemotherapy.

  • Participant has a history of moderate or severe hepatic impairment, severe renalsufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory,hematological, endocrinological, neurological or other somatic disorders.

  • Participant has unilateral orchialgia without pelvic symptoms, active urethralstricture, or neurological disease or disorder affecting the bladder.

  • Participant has uninvestigated, significant hematuria.

  • Participant has undergone transurethral prostatectomy (TURP), transurethral incisionof the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostatesurgery or treatment such as cryotherapy or thermal therapy.

  • Participant has a neurological impairment or psychiatric disorder preventing hisunderstanding of consent and his ability to comply with the protocol.

  • Participant is currently taking exclusionary medications such as potent CYP3A4inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.

Study Design

Total Participants: 272
Study Start date:
February 01, 2005
Estimated Completion Date:
January 31, 2008

Study Description

The two primary objectives of this study are:

  • To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).

  • To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization.

There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected: visit 1 involves screening, visit 2 involves collection of baseline data and randomization, visit 3 is the 6-week evaluation, and visit 4 is the 12-week evaluation of the primary end point.

Connect with a study center

  • Queen's University

    Kingston, Ontario K7L 3N6
    Canada

    Site Not Available

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Northwestern U. Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Harvard Medical School- Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Washington- Harborview Medical Center

    Seattle, Washington 98108
    United States

    Site Not Available

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