Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-22 @ 10:27 PM
Study NCT ID:
NCT03629769
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Proxelan Somministration in Patients With Chronic Prostatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011472', 'term': 'Prostatitis'}, {'id': 'D061686', 'term': 'Premature Ejaculation'}], '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'}, {'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574044', 'term': 'Proxelan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-12', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-08-12', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score', 'timeFrame': '30 days', 'description': "Evaluation of pain symptoms trough NIH-CPS questionnaires' pain items (0-6). Values from 0 to 3 normal/slight symptoms; Values from 3 to 6 moderate symptoms; Values over 6 severe symptoms."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate inflammation', 'CPS/CPPS', 'Prostatitis', 'Proxelan'], 'conditions': ['Chronic Prostatitis', 'Chronic Prostatitis With Chronic Pelvic Pain Syndrome', 'Premature Ejaculation']}, 'referencesModule': {'references': [{'pmid': '22617307', 'type': 'BACKGROUND', 'citation': 'Galeone G, Spadavecchia R, Balducci MT, Pagliarulo V. [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. Minerva Urol Nefrol. 2012 Jun;64(2):135-41. Italian.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- prostatitis like symptoms for at least three months\n\nExclusion Criteria:\n\n* significant post-voidal residual volume\n* Meares and Stamey test suggestive for bacterial infection\n* neoplasms,\n* urinary stones,\n* antibiotic therapy in the previous three months,\n* irritable bowel syndrome,\n* previous radiotherapic or chemiotherapic treatment,\n* urethral stenosis,\n* neurogenic bladder\n* previous prostatic surgery'}, 'identificationModule': {'nctId': 'NCT03629769', 'briefTitle': 'Effects of Proxelan Somministration in Patients With Chronic Prostatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study', 'orgStudyIdInfo': {'id': '1103 / 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with prostatitis-like symptoms', 'description': 'Cohort of patients with CP/CPPS (abacterial prostatitis)', 'interventionNames': ['Drug: Proxelan']}], 'interventions': [{'name': 'Proxelan', 'type': 'DRUG', 'description': 'Administration of one suppository of proxelan once a day for 30 days', 'armGroupLabels': ['Patients with prostatitis-like symptoms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56124', 'city': 'Pisa', 'state': 'Tuscany', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tommaso Di Vico, MD', 'role': 'CONTACT', 'email': 'urologiapisa@gmail.com', 'phone': '3393642655'}], 'facility': 'AOUP Ospedale cisanello', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Riccardo Bartoletti', 'investigatorAffiliation': 'University of Pisa'}}}}