Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 7:48 PM
Study NCT ID:
NCT00501267
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2007-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Test The Interaction of Two Medications for Treatment of 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': 'C523977', 'term': 'solabegron'}, {'id': 'C005419', 'term': 'oxybutynin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2007-07-13', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absorption rate of solabegron and oxybutynin', 'timeFrame': 'as measured by multiple blood draws after repeat dosing'}], 'secondaryOutcomes': [{'measure': 'To assess bladder function', 'timeFrame': 'prior to dosing Session 1 and post dose for each session'}]}, 'conditionsModule': {'keywords': ['solabegron,', 'oxybutynin,', 'healthy adults,', 'drug interaction'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males \\& females ages 18-65;\n* Body weight \\>50kg; BMI between 19-32;\n* Signed and dated informed consent; QTc Interval \\<450 msec;\n\nExclusion Criteria:\n\n* Resting blood pressure \\>140/90 mmHg or HR \\>100 at screening;\n* History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;\n* Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;\n* Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;\n* history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;\n* history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;\n* clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment'}, 'identificationModule': {'nctId': 'NCT00501267', 'briefTitle': 'A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.', 'orgStudyIdInfo': {'id': 'B3C109868'}}, 'armsInterventionsModule': {'interventions': [{'name': 'solabegron and oxybutynin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}