Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-21 @ 9:25 AM
Study NCT ID:
NCT00663806
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2008-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IV Study of Cipro XR 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7614}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2008-04-17', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.', 'timeFrame': '3-10 days after start of therapy'}], 'secondaryOutcomes': [{'measure': 'To examine the difference between physician and patient perceptions of the symptoms of uUTI.', 'timeFrame': 'At baseline visit pre-therapy'}, {'measure': 'To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting.', 'timeFrame': '1-3 days after end of therapy for efficacy and up to 30 days for safety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UTI'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.\n* Positive leukocyte esterase (\\>/= 1+) and positive nitrite test using a urine dipstick method of analysis.\n* Willing to give written consent.\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Complicated UTI\n* Allergy to Cipro XR'}, 'identificationModule': {'nctId': 'NCT00663806', 'acronym': 'EXPRESS', 'briefTitle': 'A Phase IV Study of Cipro XR in Uncomplicated UTI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction', 'orgStudyIdInfo': {'id': '100534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939)']}], 'interventions': [{'name': 'Cipro XR (Ciprofloxacin, BAYQ3939)', 'type': 'BEHAVIORAL', 'description': 'Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI', 'armGroupLabels': ['Arm 1']}, {'name': 'Cipro XR (Ciprofloxacin, BAYQ3939)', 'type': 'BEHAVIORAL', 'description': 'Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}