Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-05 @ 12:59 AM
Study NCT ID:
NCT03129295
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2017-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Proof of Concept Study in Uncomplicated UTI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on assessment instrument', 'timeFrame': '6 hours after the first dose of study drug', 'description': 'Patient reported outcome'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on assessment instruments', 'timeFrame': 'Three hour intervals after first dose of study drug', 'description': 'Patient reported outcome'}, {'measure': 'Change from baseline on Pain Scale', 'timeFrame': 'Three hour intervals after first dose of study drug', 'description': 'Patient reported outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection\n* On adequate birth control\n* Normal ECG\n\nExclusion Criteria:\n\n* Participated in any other trial within 30 days of visit 1\n* Known or suspected allergy to investigational drug\n* Narrow angle glaucoma\n* Recovering from chicken pox or flu-like symptoms\n* History of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption\n* Taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections\n* Currently taking prohibited drugs\n* Taken an antibiotic within 7 days of Visit 1\n* Are ineligible to receive an antibiotic\n* History of urinary retention\n* History of interstitial cystitis\n* History of impaired renal function\n* History of impaired hepatic function\n* Diagnosis or suspicion of complicated urinary tract infection or systemic infection\n* History of substance abuse'}, 'identificationModule': {'nctId': 'NCT03129295', 'briefTitle': 'Phase II Proof of Concept Study in Uncomplicated UTI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mission Pharmacal'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of the Efficacy and Safety of MPC-SHRC for the Relief of Symptoms Associated With Uncomplicated Urinary Tract Infections', 'orgStudyIdInfo': {'id': 'MPC-SHRC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MPC-SHRC', 'description': 'oral tablet four times a day for 3 days', 'interventionNames': ['Drug: MPC-SHRC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'oral tablet four times a day for 3 days', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'MPC-SHRC', 'type': 'DRUG', 'description': 'Oral tablet four times a day for 3 days', 'armGroupLabels': ['MPC-SHRC']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Oral tablet four times a day for 3 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'country': 'United States', 'facility': 'First Urology PSC', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beyer Research', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Lawrence OB/GYN Clinical Research, LLC', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': "Women's Health Research Center", 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}], 'centralContacts': [{'name': 'Hurley Consulting Associates', 'role': 'CONTACT', 'email': 'info@hurleyconsulting.com', 'phone': '1-908-273-8490'}], 'overallOfficials': [{'name': 'Margaret E. Hurley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hurley Consulting Associates Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mission Pharmacal', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}