Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 4:48 AM
Study NCT ID:
NCT01089751
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2010-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'C003330', 'term': 'trospium chloride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The safety population (all participants who took at least 1 dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.', 'otherNumAtRisk': 162, 'otherNumAffected': 20, 'seriousNumAtRisk': 162, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.', 'otherNumAtRisk': 158, 'otherNumAffected': 8, 'seriousNumAtRisk': 158, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Continent (PPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': 'PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Continent Days Per Week (CDW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.', 'unitOfMeasure': 'Continent days per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nocturic Toilet Voids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'A nocturic (nighttime) toilet void is identified if the patient marks "Yes" for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.', 'unitOfMeasure': 'Nocturic toilet void', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urgency-Related Toilet Voids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.6', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '3.62', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '3.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Urgency-related toilet void (or urinary urgency) is identified if the patient marks "Yes" for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.', 'unitOfMeasure': 'Toilet void', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.6', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '10.70', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '10.23', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '11.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores \\<= 30 indicate mild OAB, scores \\> 30 to 39 indicate moderate OAB, and scores \\>= 40 indicate severe OAB. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Voided Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '183.5', 'spread': '79.78', 'groupId': 'OG000'}, {'value': '187.4', 'spread': '78.76', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '20.6', 'spread': '89.62', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '71.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.', 'unitOfMeasure': 'cubic centimeters (cc)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urgency Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urgency Urinary Incontinence (UUI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 14', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 14', 'description': 'Urgency urinary incontinence is identified if the patient marks "Yes" for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'UUI episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked "Yes" for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '76'}, {'value': '56.0', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '84'}, {'value': '56.1', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-24', 'studyFirstSubmitDate': '2010-03-17', 'resultsFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-24', 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Continent (PPC)', 'timeFrame': 'Week 14', 'description': 'PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Continent Days Per Week (CDW)', 'timeFrame': 'Baseline, Week 14', 'description': 'Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.'}, {'measure': 'Change From Baseline in Nocturic Toilet Voids', 'timeFrame': 'Baseline, Week 14', 'description': 'A nocturic (nighttime) toilet void is identified if the patient marks "Yes" for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.'}, {'measure': 'Change From Baseline in Urgency-Related Toilet Voids', 'timeFrame': 'Baseline, Week 14', 'description': 'Urgency-related toilet void (or urinary urgency) is identified if the patient marks "Yes" for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.'}, {'measure': 'Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)', 'timeFrame': 'Baseline, Week 14', 'description': 'The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores \\<= 30 indicate mild OAB, scores \\> 30 to 39 indicate moderate OAB, and scores \\>= 40 indicate severe OAB. A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Voided Volume', 'timeFrame': 'Baseline, Week 14', 'description': 'Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.'}, {'measure': 'Change From Baseline in Urgency Severity', 'timeFrame': 'Baseline, Week 14', 'description': 'The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Urgency Urinary Incontinence (UUI)', 'timeFrame': 'Baseline, Week 14', 'description': 'Urgency urinary incontinence is identified if the patient marks "Yes" for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification\n* Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence\n* Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).\n\nExclusion Criteria:\n\n* Predominant stress or insensate incontinence\n* History of neurogenic bladder\n* Two urinary tract infections in the last six months\n* Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)\n* Donated \\>500mL blood in the 30 days prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT01089751', 'briefTitle': 'Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-SXR-09-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sanctura XR®', 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.', 'interventionNames': ['Drug: trospium chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily on an empty stomach for 14 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'trospium chloride', 'type': 'DRUG', 'otherNames': ['Sanctura XR®'], 'description': 'Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks', 'armGroupLabels': ['Sanctura XR®']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo once daily on an empty stomach for 14 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}