Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00190905
Status:
COMPLETED
Last Update Posted:
2006-07-25
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 4000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2005-07'}, 'lastUpdateSubmitDate': '2006-07-21', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in weekly incontinence episode frequency as noted by patient diaries from baseline to endpoint in Hispanic women and also in African American women with SUI or stress predominant mixed urinary incontinence'}], 'secondaryOutcomes': [{'measure': 'Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries'}]}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.\n* Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.\n* Must provide informed consent.\n* Must not have urinary tract infection at screening.\n\nExclusion Criteria:\n\n* Sensitivity to duloxetine\n* Unstable medical conditions\n* Pregnancy\n* Acute liver damage\n* Suicidal in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT00190905', 'briefTitle': 'Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-Morbidities With Stress Urinary Incontinence: Evaluation of Efficacy and Safety', 'orgStudyIdInfo': {'id': '8363'}, 'secondaryIdInfos': [{'id': 'F1J-US-SBCD'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'duloxetine HCl', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}]}}}