Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00103402
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2005-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011472', 'term': 'Prostatitis'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047638', 'term': 'alfuzosin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hultman@upenn.edu', 'phone': '215-573-4922', 'title': 'J. Richard Landis, PhD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks', 'otherNumAtRisk': 138, 'deathsNumAtRisk': 138, 'otherNumAffected': 40, 'seriousNumAtRisk': 138, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 46, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constitutional events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in any body system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Spontaneous pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic head laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '11.0', 'groupDescription': "Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.", 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.', 'nonInferiorityComment': '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.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 12 weeks', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Response Assessment (GRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'categories': [{'title': 'Marked improvement', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Moderate improvement', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Slight improvement', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Slight worsening', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Moderate worsening', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Marked worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '2.5', 'groupDescription': 'Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '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.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Change in Subscales of the NIH-CPSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Pain score', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Urinary score', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Quality-of-life score', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.5', 'groupDescription': 'Total score (0-43) change from baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.8', 'groupDescription': 'Pain score (0-21) change from baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.4', 'groupDescription': 'Urinary score (0-10) change from baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Quality of life score (0-12) change from baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and12 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Subscales of the McGill Pain Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Sensory score', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Affective score', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.2', 'groupDescription': 'McGill Total Score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.0', 'groupDescription': 'McGill Sensory Score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'groupDescription': 'McGill Affective Score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Medical Outcomes Study Short Form 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'title': 'Physical component', 'categories': [{'measurements': [{'value': '3.0', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Mental component', 'categories': [{'measurements': [{'value': '4.0', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '1.3', 'groupDescription': 'Physical component summary (0-100) change in scores', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '4.6', 'groupDescription': 'Mental component summary (0-100) Absolute Difference between Groups (95% CI)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hospital Anxiety and Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in International Index of Erectile Dysfunction (IIEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '14.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '4.0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Male Sexual Health Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.5', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Dissatisfied/No longer interested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Personal constraints/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.1', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NIH-CPSI', 'classes': [{'title': 'Total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '24.5', 'spread': '6.1', 'groupId': 'BG002'}]}]}, {'title': 'Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '11.5', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '3.4', 'groupId': 'BG002'}]}]}, {'title': 'Urinary score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '2.9', 'groupId': 'BG002'}]}]}, {'title': 'Quality of life score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Likert Pain and Urgency Scale', 'classes': [{'title': 'Average pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '2.0', 'groupId': 'BG002'}]}]}, {'title': 'Urgency score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on the scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'McGill Pain Questionnaire', 'classes': [{'title': 'Total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '11.6', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '11.4', 'spread': '8.7', 'groupId': 'BG002'}]}]}, {'title': 'Sensory score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '6.1', 'groupId': 'BG002'}]}]}, {'title': 'Affective score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on completed questionnaires'}, {'title': 'SF-12', 'classes': [{'title': 'Physical component summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '45.6', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '45.6', 'spread': '9.0', 'groupId': 'BG002'}]}]}, {'title': 'Mental component summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.0', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '44.5', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on completed questionnaires'}, {'title': 'Hospital Anxiety and Depression Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '12.8', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '12.8', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on completed questionnaires'}, {'title': 'International Index of Erectile Function', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '17.9', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '17.4', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '17.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on completed questionnaires'}, {'title': 'Male Sexual Health Questionnaire', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on completed questionnaires'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2005-02-07', 'resultsFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2005-02-07', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-27', 'studyFirstPostDateStruct': {'date': '2005-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Global Response Assessment (GRA)', 'timeFrame': '12 weeks', 'description': '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).'}, {'measure': 'Change in Subscales of the NIH-CPSI', 'timeFrame': 'Baseline and12 weeks', 'description': '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.'}, {'measure': 'Change in Subscales of the McGill Pain Questionnaire', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.'}, {'measure': 'Change in Medical Outcomes Study Short Form 12', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.'}, {'measure': 'Change in Hospital Anxiety and Depression Scale', 'timeFrame': 'Baseline and 12 weeks', 'description': 'For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.'}, {'measure': 'Change in International Index of Erectile Dysfunction (IIEF)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.'}, {'measure': 'Change in Male Sexual Health Questionnaire', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostatitis', 'Non-bacterial Prostatitis', 'Prostatodynia', 'Alfuzosin', 'Alpha-adrenergic blocker'], 'conditions': ['Prostatitis']}, 'referencesModule': {'references': [{'pmid': '15492337', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12521581', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15364307', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12131316', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12031372', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12521576', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19092152', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'The two primary objectives of this study are:\n\n* 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).\n* To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.\n\nThe 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.\n\nThere 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has signed and dated the appropriate Informed Consent document.\n* Participant is male.\n* Participant is at least 18 years of age.\n* Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.\n* Symptoms bothersome enough to prompt a physician visit have been present for two years or less.\n\nExclusion Criteria:\n\n* Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).\n* Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.\n* Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.\n* Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.\n* Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.\n* Participant has uninvestigated, significant hematuria.\n* Participant has undergone transurethral prostatectomy (TURP), transurethral incision of 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 prostate surgery or treatment such as cryotherapy or thermal therapy.\n* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.\n* Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.'}, 'identificationModule': {'nctId': 'NCT00103402', 'briefTitle': 'Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CPCRN2 Afluzosin'}, 'secondaryIdInfos': [{'id': 'RFA-DK-03-004', 'type': 'OTHER_GRANT', 'domain': 'NIDDK'}, {'id': 'U01DK065209', 'link': 'https://reporter.nih.gov/quickSearch/U01DK065209', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alfuzosin', 'description': '10 mg of alfuzosin once daily for 12 weeks', 'interventionNames': ['Drug: Alfuzosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10 mg of an identical-looking placebo once daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Alfuzosin', 'type': 'DRUG', 'armGroupLabels': ['Alfuzosin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern U. Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Medical School- Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington- Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Leroy Nyberg, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, {'name': 'John Kusek, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'url': 'https://repository.niddk.nih.gov/studies/cpcrn2-rct1/?query=CPCRN', 'ipdSharing': 'YES', 'description': 'Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/cpcrn2-rct1/?query=CPCRN'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}