Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT00103402|
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostatitis||Drug: Alfuzosin Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||272 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized 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|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
10 mg of alfuzosin once daily for 12 weeks
Placebo Comparator: Placebo
10 mg of an identical-looking placebo once daily for 12 weeks
- Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks [ Time Frame: Baseline and 12 weeks ]For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks
- Global Response Assessment (GRA) [ Time Frame: 12 weeks ]The response rate for the global response assessment was based on marked or moderate improvement at 12 weeks using a 7 point scale (marked worsening, moderate worsening, no change, slight improvement, moderate improvement, marked improvement).
- Change in Subscales of the NIH-CPSI [ Time Frame: Baseline and12 weeks ]For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI), higher scores indicate more severe symptoms (for the quality-of-life score, higher scores indicate a more negative effect). Score ranges are as follows: total score, 0 to 43; pain score, 0 to 21; urinary score, 0 to 10, quality-of-life score, 0 to 12; and average pain and urgency scores, 0 to 10.
- Change in Subscales of the McGill Pain Questionnaire [ Time Frame: Baseline and 12 weeks ]For the McGill Pain Questionnaire, higher scores indicate greater pain. Score ranges are as follows: total score, 0 to 45; sensory score, 0 to 33; affective score, 0 to 12.
- Change in Medical Outcomes Study Short Form 12 [ Time Frame: Baseline and 12 weeks ]For the Medical Outcomes Study Short Form Health Survey 12 (SF-12), higher scores indicate better quality of life. Score range for both the physical and mental component summaries is 0 to 100.
- Change in Hospital Anxiety and Depression Scale [ Time Frame: Baseline and 12 weeks ]For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.
- Change in International Index of Erectile Dysfunction (IIEF) [ Time Frame: Baseline and 12 weeks ]For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.
- Change in Male Sexual Health Questionnaire [ Time Frame: Baseline and 12 weeks ]For the Male Sexual Health Questionnaire, higher scores indicate better function with respect to erection and ejaculation and greater satisfaction with sexual life; range, 0 to 40.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103402
|United States, California|
|David Geffen School of Medicine at UCLA|
|Los Angeles, California, United States, 90095|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|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, Ohio, United States, 44195|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|United States, Washington|
|University of Washington- Harborview Medical Center|
|Seattle, Washington, United States, 98108|
|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)|