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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00103402 |
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
Condition | Intervention | Phase |
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Prostatitis |
Drug: Alfuzosin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Multicenter Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS) in Recently-Diagnosed and/or Newly-Symptomatic Alpha-Blocker Naïve Patients |
Estimated Enrollment: | 270 |
Study Start Date: | February 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
The two primary objectives of this study are:
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 clinic visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
David Geffen School of Medicine at UCLA | |
Los Angeles, California, United States, 90095 | |
United States, Illinois | |
Northwestern U. Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Harvard Medical School- Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Temple University | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Washington | |
University of Washington- Harborview Medical Center | |
Seattle, Washington, United States, 98108 | |
Canada, Ontario | |
Queen's University | |
Kingston, Ontario, Canada, K7L 3N6 |
Study Director: | Leroy Nyberg, MD PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Study Director: | John Kusek, PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Study ID Numbers: | cp/cpps, RFA-DK-03-004 |
Study First Received: | February 7, 2005 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00103402 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Prostatitis Non-bacterial Prostatitis Prostatodynia Alfuzosin Alpha-adrenergic blocker |
Neurotransmitter Agents Prostatic Diseases Adrenergic Agents Pain Adrenergic alpha-Antagonists Cardiovascular Agents Genital Diseases, Male |
Antihypertensive Agents Prostatitis Signs and Symptoms Pelvic Pain Alfuzosin Adrenergic Antagonists |
Neurotransmitter Agents Prostatic Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pain Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents |
Genital Diseases, Male Pharmacologic Actions Prostatitis Signs and Symptoms Pelvic Pain Alfuzosin Therapeutic Uses Adrenergic Antagonists |