Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-29 @ 5:55 AM
Study NCT ID:
NCT01578304
Status:
COMPLETED
Last Update Posted:
2012-04-16
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C120953', 'term': 'imidafenacin'}, {'id': 'C526675', 'term': 'fesoterodine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-13', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)', 'timeFrame': 'up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Adverse events', 'timeFrame': 'up to 24 weeks'}, {'measure': 'laboratory test', 'timeFrame': 'up to 12 weeks'}, {'measure': 'vital signs', 'timeFrame': 'up to 12 weeks'}, {'measure': 'residual urine', 'timeFrame': 'up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive bladder'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with overactive bladder aged 20 years or more\n* subject who had the continuos symptom for 3 months or more\n* subject prepare a symptom diary and was deemed eligible for the study by the investigator\n* 8 times or more of daily mean urination frequency\n* 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency\n\nExclusion Criteria:\n\n* subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year\n* subjects with diseases prohibiting anti-cholinergics from administration\n* subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications\n* subjects who received lower urinary tract surgery within 6 months\n* subjects with a catheter placed or intermittent catheterization\n* subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period\n* subjects who are within 1 month after other clinical study was completed\n* subjects having 100mL or more of residual urine\n* subjects who had acute urinary retention history\n* subjects who have been administered Prohibited concomitant medications'}, 'identificationModule': {'nctId': 'NCT01578304', 'briefTitle': 'Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder', 'orgStudyIdInfo': {'id': 'LG-IFCL002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imidafenacin', 'interventionNames': ['Drug: Imidafenacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fesoterodine', 'interventionNames': ['Drug: Fesoterodine']}], 'interventions': [{'name': 'Imidafenacin', 'type': 'DRUG', 'description': 'Tablet, 12 weeks twice daily', 'armGroupLabels': ['Imidafenacin']}, {'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Tablet, 12 weeks once daily', 'armGroupLabels': ['Fesoterodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'KYU-SUNG LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyorin Pharmaceutical Co.,Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}