Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT00371033
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2006-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': '6 weeks', 'description': 'Final Adverse Events were reported by arm. They included all AEs by type, regardless of their relationship to study drug.\n\nPatients are counted once in each category and included in the column relating to their worst toxicity grade. Patients may have had events in more than one body system category. An adverse event is not counted if the same event is observed at baseline with an equal or greater toxicity grade.', 'eventGroups': [{'id': 'EG000', 'title': '1-Pregabalin', 'description': 'Randomized to Pregabalin', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 129, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2-Placebo', 'description': 'Randomized to placebo', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 62, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'notes': 'All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 38, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Constitutional symptoms', 'notes': 'All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Neurologic symptoms', 'notes': 'All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Gastrointestinal disturbance', 'notes': 'All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Ocular/visual symptoms', 'notes': 'All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}, {'term': 'Renal/genitourinary symptoms', 'notes': 'All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (6.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Decrease in the NIH-CPSI Total Score by at Least 6 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Randomized to Pregabalin'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Randomized to placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subscales of the NIH-CPSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '19.7', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Pain domain score', 'categories': [{'measurements': [{'value': '9.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Urinary symptoms domain score', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Quality of life domain', 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.', 'unitOfMeasure': 'units on the NIH-CPSI scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed in the secondary outcome measures were 210 for the pregabalin arm and 103 for the placebo arm.'}, {'type': 'SECONDARY', 'title': 'Moderately or Markedly Improve on Global Response Assessment (GRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety & Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'McGill Pain Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study Short Form 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'classes': [{'title': 'Physical [PCS] Component Summary', 'categories': [{'measurements': [{'value': '46.9', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '44.3', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Mental [MCS] Component Summary', 'categories': [{'measurements': [{'value': '45.0', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical \\[PCS\\] and Mental \\[MCS\\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sexual Health Inventory for Men', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'OG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'FG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'No longer interested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Uknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1-Pregabalin', 'description': 'Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'BG001', 'title': '2-Placebo', 'description': 'Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '47.0', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NIH-CPSI total score (possible score, 0-43)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '26.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NIH-CPSI pain subscore (possible score, 0-21)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '12.4', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscore is determined by location, frequency, and severity of pain symptoms with a possible score of 0-21. A higher score indicates more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NIH-CPSI urinary symptoms subscore (possible score, 0-10)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary subscore measures irritative and obstructive symptoms with a possible score of 0-10. A higher score indicates more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NIH-CPSI QOL subscore (possible score, 0-12)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) impact/quality of life subscore measures participant-reported symptoms with a possible score, 0-12. A higher score indicates more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SF-12 PCS score (possible score, 0-100)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '44.6', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Medical Outcomes Study 12-item Short Form Survey (SF-12) is a general health questionnaire that is comprised of a mental component score (MCS-12) and a physical component score (PCS-12). The SF-12 ranges from 0-100 for the Physical \\[PCS\\] and Mental \\[MCS\\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on evaluable patient data'}, {'title': 'SF-12 MCS score (possible score, 0-100)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Medical Outcomes Study 12-item Short Form Survey (SF-12) is a general health questionnaire that is comprised of a mental component score (MCS-12) and a physical component score (PCS-12). The SF-12 ranges from 0-100 for the Physical \\[PCS\\] and Mental \\[MCS\\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Based on evaluable patient data'}], 'populationDescription': 'Based on evaluable participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2008-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2006-08-31', 'resultsFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2006-08-31', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-18', 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in the NIH-CPSI Total Score by at Least 6 Points', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.'}], 'secondaryOutcomes': [{'measure': 'Subscales of the NIH-CPSI', 'timeFrame': '6 weeks', 'description': 'The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.'}, {'measure': 'Moderately or Markedly Improve on Global Response Assessment (GRA)', 'timeFrame': '6 weeks', 'description': 'The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders.'}, {'measure': 'Hospital Anxiety & Depression Scale', 'timeFrame': '6 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression)'}, {'measure': 'McGill Pain Questionnaire', 'timeFrame': '6 weeks', 'description': 'The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain.'}, {'measure': 'Medical Outcomes Study Short Form 12', 'timeFrame': '6 weeks', 'description': 'Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical \\[PCS\\] and Mental \\[MCS\\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life)'}, {'measure': 'Sexual Health Inventory for Men', 'timeFrame': '6 weeks', 'description': 'Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)']}, 'referencesModule': {'references': [{'pmid': '20876412', 'type': 'DERIVED', 'citation': "Pontari MA, Krieger JN, Litwin MS, White PC, Anderson RU, McNaughton-Collins M, Nickel JC, Shoskes DA, Alexander RB, O'Leary M, Zeitlin S, Chuai S, Landis JR, Cen L, Propert KJ, Kusek JW, Nyberg LM Jr, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network-2. Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1586-93. doi: 10.1001/archinternmed.2010.319."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.', 'detailedDescription': 'Primary Objectives\n\n1. To compare six (6) weeks of treatment with pregabalin versus placebo in CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI\n2. To evaluate the safety and tolerability of six (6) weeks of pregabalin in CP/CPPS participants\n\nDesign\n\nEligible participants will receive either pregabalin or placebo, randomly assigned at a ratio of 2:1. Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily, to maximum tolerated dose. Participants will be advised to take the study medication 3 times per day. There are 3 clinic visits and 2 telephone contacts. Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks. For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts.'}, '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 must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.\n\nExclusion Criteria:\n\n* Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment.\n* Participant has a calculated creatinine clearance of \\<60 mL/min.\n* Participant has a platelet count \\<100,000/mm3.\n* Participant is allergic to antiepileptic/antiseizure medications.\n* Participant has a known allergy or sensitivity to pregabalin (Lyrica®).\n* Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone).\n* Participant has New York Heart Association Class III or IV congestive heart failure.\n* Participant has a history of thrombocytopenia, or a bleeding diathesis.\n* Participant has a history of prostate, bladder or urethral cancer.\n* Participant has a history of alcohol abuse.\n* Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).\n* Participant has undergone pelvic radiation or systemic chemotherapy.\n* Participant has undergone intravesical chemotherapy.\n* Participant has been treated with intravesical BCG.\n* Participant has unilateral orchalgia without other pelvic symptoms.\n* Participant has an active urethral stricture.\n* Participant has a neurological disease or disorder affecting the bladder.\n* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol."}, 'identificationModule': {'nctId': 'NCT00371033', 'acronym': 'CPCRN RCT#2', 'briefTitle': 'Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)', 'orgStudyIdInfo': {'id': 'CPCRN2 Pregabalin'}, 'secondaryIdInfos': [{'id': 'U01DK065209', 'link': 'https://reporter.nih.gov/quickSearch/U01DK065209', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Pregabalin 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo at same frequency as pregabablin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charles R Drew University of Medicine & Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1738', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305-5118', '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 University 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': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Medical School', '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 Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University School of Medicine', '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 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'John Kusek, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, {'name': 'Lee Nyberg, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'url': 'https://repository.niddk.nih.gov/studies/cpcrn2-rct2/?query=cpcrn2', 'ipdSharing': 'YES', 'description': 'Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/cpcrn2-rct2/?query=cpcrn2'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}