Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02094703
Status:
UNKNOWN
Last Update Posted:
2014-03-24
First Post:
2014-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-19', 'studyFirstSubmitDate': '2014-03-10', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with storage symptoms', 'timeFrame': 'up to three days'}]}, 'conditionsModule': {'keywords': ['female', 'age 18-65 years', 'storage symptoms', 'clinical urinary tract infection', 'non complicated'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females (18-65 years old)\n* dysuria in symptomatic non complicated urinary tract infection\n\nExclusion Criteria:\n\n* Pediatric Patients (\\< 18 years old)\n* geriatric Patients (\\> 65 years old)\n* pregnant Patients\n* Patients with complicated urinary tract infection\n* sexually transmitted infections\n* Patients with pathological abnormalities in the urinary bladder, including stone/mass\n* Catheter-mounted\n* Neurological diseases/disorders\n* patients with allergy/hypersensitivity with Levofloxacin/Solifenacin'}, 'identificationModule': {'nctId': 'NCT02094703', 'briefTitle': 'The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': 'The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females', 'orgStudyIdInfo': {'id': 'URO-SOL-01-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'levofloxacin and solifenacin succinate', 'description': 'Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days', 'interventionNames': ['Drug: Levofloxacin', 'Drug: Solifenacin succinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'levofloxacin and placebo', 'description': 'Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days', 'interventionNames': ['Drug: Levofloxacin', 'Drug: Placebo (for Solifenacin succinate)']}], 'interventions': [{'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['neslav'], 'armGroupLabels': ['levofloxacin and placebo', 'levofloxacin and solifenacin succinate']}, {'name': 'Solifenacin succinate', 'type': 'DRUG', 'armGroupLabels': ['levofloxacin and solifenacin succinate']}, {'name': 'Placebo (for Solifenacin succinate)', 'type': 'DRUG', 'armGroupLabels': ['levofloxacin and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Harrina Erlianti Rahardjo', 'role': 'CONTACT', 'email': 'harrinaerlianti@yahoo.com', 'phone': '+62 816-825-226'}], 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Indonesia Inc.', 'class': 'INDUSTRY'}, {'name': 'Pharos Life Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Harrina Erlianti Rahardjo,MD,PhD', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}