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| ID | Type | Description | Link |
|---|---|---|---|
| RFA-DK-03-004 | Other Grant/Funding Number | NIDDK | |
| U01DK065209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfuzosin | Experimental | 10 mg of alfuzosin once daily for 12 weeks |
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| Placebo | Placebo Comparator | 10 mg of an identical-looking placebo once daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfuzosin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 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 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Response Assessment (GRA) | 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). | 12 weeks |
| Change in Subscales of the NIH-CPSI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States | ||
| Stanford University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15492337 | Background | Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS; Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004 Oct 19;141(8):581-9. doi: 10.7326/0003-4819-141-8-200410190-00005. | |
| 12521581 |
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Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/cpcrn2-rct1/?query=CPCRN
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| ID | Title | Description |
|---|---|---|
| FG000 | Alfuzosin | 10 mg of alfuzosin once daily for 12 weeks |
| FG001 | Placebo | 10 mg of an identical-looking placebo once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| Baseline and12 weeks |
| Change in Subscales of the McGill Pain Questionnaire | 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. | Baseline and 12 weeks |
| Change in Medical Outcomes Study Short Form 12 | 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. | Baseline and 12 weeks |
| Change in Hospital Anxiety and Depression Scale | For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42. | Baseline and 12 weeks |
| Change in International Index of Erectile Dysfunction (IIEF) | For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75. | Baseline and 12 weeks |
| Change in Male Sexual Health Questionnaire | 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. | Baseline and 12 weeks |
| Stanford |
| California |
| 94305 |
| United States |
| Northwestern U. Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Harvard Medical School- Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| University of Washington- Harborview Medical Center | Seattle | Washington | 98108 | United States |
| Queen's University | Kingston | Ontario | K7L 3N6 | Canada |
| Background |
| Litwin MS. A review of the development and validation of the National Institutes of Health Chronic Prostatitis Symptom Index. Urology. 2002 Dec;60(6 Suppl):14-8; discussion 18-9. doi: 10.1016/s0090-4295(02)02296-3. |
| 15364307 | Background | Schaeffer AJ; National Institute of Diabetes and Digestive and Kidney Diseases of the US National Institutes of Health. NIDDK-sponsored chronic prostatitis collaborative research network (CPCRN) 5-year data and treatment guidelines for bacterial prostatitis. Int J Antimicrob Agents. 2004 Sep;24 Suppl 1:S49-52. doi: 10.1016/j.ijantimicag.2004.02.009. |
| 12131316 | Background | Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O'Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM; Chronic Prostatitis Collaborative Research Network Group. Demographic and clinical characteristics of men with chronic prostatitis: the national institutes of health chronic prostatitis cohort study. J Urol. 2002 Aug;168(2):593-8. |
| 12031372 | Background | Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016/s0090-4295(02)01601-1. |
| 12521576 | Background | Schaeffer AJ, Datta NS, Fowler JE Jr, Krieger JN, Litwin MS, Nadler RB, Nickel JC, Pontari MA, Shoskes DA, Zeitlin SI, Hart C; Chronic Prostatitis Collaborative Research Network. Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Urology. 2002 Dec;60(6 Suppl):1-4. doi: 10.1016/s0090-4295(02)01979-9. |
| 19092152 | Result | Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alfuzosin | 10 mg of alfuzosin once daily for 12 weeks |
| BG001 | Placebo | 10 mg of an identical-looking placebo once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| NIH-CPSI | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Likert Pain and Urgency Scale | For the Likert Pain and Urinary Urgency Scale, a score of 0 indicates no pain or urgency and a score of 10 indicates the most severe pain or urgency. | Mean | Standard Deviation | units on the scale |
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| McGill Pain Questionnaire | 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. | Based on completed questionnaires | Mean | Standard Deviation | units on a scale |
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| SF-12 | 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. | Based on completed questionnaires | Mean | Standard Deviation | units on a scale |
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| Hospital Anxiety and Depression Scale | For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42. | Based on completed questionnaires | Mean | Standard Deviation | units on a scale |
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| International Index of Erectile Function | For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75. | Based on completed questionnaires | Mean | Standard Deviation | units on a scale |
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| Male Sexual Health Questionnaire | 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. | Based on completed questionnaires | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 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 | Posted | Count of Participants | Participants | Baseline and 12 weeks |
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| Secondary | Global Response Assessment (GRA) | 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). | The analysis population for this outcome is larger than the number of participants who completed the trial because a few participant answered this question without completing the other questionnaires | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Change in Subscales of the NIH-CPSI | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and12 weeks |
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| Secondary | Change in Subscales of the McGill Pain Questionnaire | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Medical Outcomes Study Short Form 12 | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Hospital Anxiety and Depression Scale | For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in International Index of Erectile Dysfunction (IIEF) | For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Male Sexual Health Questionnaire | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Alfuzosin | 10 mg of alfuzosin once daily for 12 weeks | 0 | 138 | 1 | 138 | 40 | 138 |
| EG001 | Placebo | 10 mg of an identical-looking placebo once daily for 12 weeks | 0 | 134 | 2 | 134 | 46 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Traumatic head laceration | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constitutional events | General disorders | Systematic Assessment |
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| Gastrointestinal events | Gastrointestinal disorders | Systematic Assessment |
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| Neurologic events | Nervous system disorders | Systematic Assessment |
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| Pain in any body system | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Richard Landis, PhD | University of Pennsylvania | 215-573-4922 | hultman@upenn.edu |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
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| C047638 | alfuzosin |
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The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center. |
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