Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 5:01 AM
Study NCT ID:
NCT01598103
Status:
TERMINATED
Last Update Posted:
2020-12-19
First Post:
2012-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2020-08-20', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2012-02-17', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2012-05-14', 'dispFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum cystometric capacity (MCC)', 'timeFrame': '1 week', 'description': 'Examined during filling cystometry as measured by changes from baseline following treatment for one week.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety', 'timeFrame': '1 week', 'description': 'Safety (physical exam, vital signs, haematology, coagulation parameters, clinical chemistry and urinalysis, ECG, pregnancy test, hand immersion test and PK \\[concentrations of SAF312 in blood\\]).'}, {'measure': 'Bladder threshold vol, threshold pressure, instilled vol at first leak, detrusor pressure at first leak, vol/detrusor pressure at first sensation and at first desire to void, maximum detrusor pressure during filling/storage, bladder wall compliance', 'timeFrame': '1 week', 'description': 'All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week'}, {'measure': 'Micturition or catheterization frequency', 'timeFrame': '1 week', 'description': 'Changes from baseline, as measured by daily diaries.'}, {'measure': 'Incontinence episodes', 'timeFrame': '1 week', 'description': 'Changes from baseline as measured by daily diaries.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurogenic detrusor overactivity', 'spinal cord lesions', 'spinal cord injury'], 'conditions': ['Neurogenic Urinary Bladder', 'Neurogenic Bladder Disorder', 'Neurogenic Dysfunction of the Urinary Bladder', 'Neurogenic Bladder, Uninhibited', 'Neurogenic Bladder, Spastic']}, 'referencesModule': {'references': [{'pmid': '11857671', 'type': 'BACKGROUND', 'citation': 'Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.'}, {'pmid': '11948720', 'type': 'BACKGROUND', 'citation': 'Schafer W, Abrams P, Liao L, Mattiasson A, Pesce F, Spangberg A, Sterling AM, Zinner NR, van Kerrebroeck P; International Continence Society. Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn. 2002;21(3):261-74. doi: 10.1002/nau.10066.'}, {'pmid': '19403235', 'type': 'BACKGROUND', 'citation': 'Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9783', 'label': 'Results for CSAF312A2202 on the Novartis clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with neurogenic detrusor overactivity due to spinal cord lesions\n* Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL\n\nExclusion Criteria:\n\n* Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs\n* Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function'}, 'identificationModule': {'nctId': 'NCT01598103', 'briefTitle': 'Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety and Tolerability of SAF312 in Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions Who Are Inadequately Managed by Antimuscarinic Therapy', 'orgStudyIdInfo': {'id': 'CSAF312A2202'}, 'secondaryIdInfos': [{'id': '2010-021137-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to SAF312', 'interventionNames': ['Drug: Placebo to SAF312']}, {'type': 'EXPERIMENTAL', 'label': 'SAF312', 'interventionNames': ['Drug: SAF312']}], 'interventions': [{'name': 'SAF312', 'type': 'DRUG', 'description': 'One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)', 'armGroupLabels': ['SAF312']}, {'name': 'Placebo to SAF312', 'type': 'DRUG', 'description': 'One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)', 'armGroupLabels': ['Placebo to SAF312']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-82419', 'city': 'Murnau am Staffelsee', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.68085, 'lon': 11.20125}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}