Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT00335660
Status:
TERMINATED
Last Update Posted:
2008-02-25
First Post:
2006-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'whyStopped': 'Animal Safety Data', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-15', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-09', 'lastUpdatePostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity'}], 'secondaryOutcomes': [{'measure': 'Delay of the first involuntary detrusor contraction associated with symptomatic urgency'}, {'measure': 'Urgency, frequency and urge incontinence events as recorded in the Subject Micturition Diary'}, {'measure': 'Urgency Perception Scale'}]}, 'conditionsModule': {'keywords': ['Idiopathic Detrusor Overactivity', 'NK-1 Receptor Antagonist', 'Neurokinin', 'Urge Incontinence'], 'conditions': ['Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.', 'detailedDescription': 'This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity. Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial.\n\nEligible subjects will complete a baseline urodynamic assessment. All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo. At the end of the treatment period, subjects will complete a second urodynamic assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, 18 to 65 years of age, inclusive\n* A current primary diagnosis of OAB\n* Idiopathic detrusor overactivity, demonstrated by a urodynamic observation\n* Evidence of frequency in combination with urinary urgency\n* Written informed consent form\n* Willingness to avoid pregnancy and practice adequate birth control\n* Negative serum pregnancy test\n* Agrees to refrain from blood donation during the course of the study\n\nExclusion Criteria:\n\n* Subjects who are pregnant or lactating\n* Clinically significant abnormality or clinically significant unstable medical condition\n* QTc interval of 470 msec or greater at Visit 1\n* Predominant stress urinary incontinence versus urge urinary incontinence based on subject history\n* Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.)\n* Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system\n* Urological or gynecological surgery within 3 months of the baseline urodynamic assessment\n* Current UTI or frequent UTIs (i.e., greater than or equal to 4 UTIs per year), interstitial cystitis, hematuria of unknown cause, or use of indwelling catheter\n* Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Visit 1\n* History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria\n* History of any kind of cancer within the last 2 years\n* Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract'}, 'identificationModule': {'nctId': 'NCT00335660', 'briefTitle': 'Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avera Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity', 'orgStudyIdInfo': {'id': 'AV608-106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AV608', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Zeist', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09, 'lon': 5.23333}}, {'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Blackburn', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'city': 'Chertsey', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Plymouth', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Falkirk', 'state': 'Scotland', 'country': 'United Kingdom', 'geoPoint': {'lat': 56.0021, 'lon': -3.78535}}], 'overallOfficials': [{'name': 'Linda Cardozo, MD FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}, {'name': 'Joao Siffert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avera Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avera Pharmaceuticals', 'class': 'INDUSTRY'}}}}