Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00919893
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2009-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010070', 'term': 'cernilton'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wagenlehner@AOL.com', 'phone': '0049 641 9944518', 'title': 'Dr. F.M.E. Wagenlehner', 'organization': 'Clinic for urology and pediatric urology, JL-University, Giessen, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cernilton', 'description': 'Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0, 6, 12 weeks', 'description': 'Decrease of score points. Decrease of leucocytes in urine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cernilton', 'description': 'Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).\n\nPower calculation: A power of 1-beta=0.8 was calculated.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0, 6, 12 weeks', 'description': 'Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intention to treat) LOCF (Last observation carried forward)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cernilton', 'description': 'Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Outpatients at urologic clinics. Start date: December 1999. Stop date: January 2004.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cernilton', 'description': 'Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '39.5', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2009-02-10', 'resultsFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-27', 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)', 'timeFrame': '0, 6, 12 weeks', 'description': 'Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.', 'timeFrame': '0, 6, 12 weeks', 'description': 'Decrease of score points. Decrease of leucocytes in urine.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic prostatitis symptom index', 'male', 'inflammatory', 'CP-CPPS', 'Cernilton', 'pelvic pain', 'symptoms'], 'conditions': ['Chronic Prostatitis', 'Chronic Pelvic Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '8499988', 'type': 'BACKGROUND', 'citation': 'Rugendorff EW, Weidner W, Ebeling L, Buck AC. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol. 1993 Apr;71(4):433-8. doi: 10.1111/j.1464-410x.1993.tb15988.x.'}]}, 'descriptionModule': {'briefSummary': 'In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.', 'detailedDescription': 'We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men between 18 and 65 years\n* symptoms of pelvic pain for at least 3 months during the 6 months before study entry\n* a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher\n* leukocytes of 10 or more in post prostate massage urine\n\nExclusion Criteria:\n\n* urinary tract infection\n* acute bacterial or chronic bacterial prostatitis\n* history of urethritis with discharge 4 weeks prior to study entry\n* a history of epididymitis or sexually transmitted disease\n* residual urine volume of more than 50 mL due to bladder outlet obstruction\n* indication for or history of prostate surgery including prostate biopsy\n* treatment with phytotherapeutic agents\n* alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry\n* treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry'}, 'identificationModule': {'nctId': 'NCT00919893', 'briefTitle': 'Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome', 'orgStudyIdInfo': {'id': '4015497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cernilton', 'description': 'Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)', 'interventionNames': ['Drug: Cernilton']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cernilton', 'type': 'DRUG', 'description': 'Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.', 'armGroupLabels': ['Cernilton']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Justus-Liebig-University', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Wolfgang Weidner, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Strathmann AG&Co, Hamburg, Germany', 'class': 'UNKNOWN'}, {'name': 'Cernelle, Ängelholm, Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Wolfgang Weidner', 'oldOrganization': 'Clinic for Urology and Pediatric Urology, JL-University, Giessen, Germany'}}}}