Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 7:35 AM
Study NCT ID:
NCT00517868
Status:
TERMINATED
Last Update Posted:
2024-08-23
First Post:
2007-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@vaneltix.com', 'phone': '732-354-3217', 'title': 'CEO', 'organization': 'Vaneltix Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was intended to include 40 subjects, but it had to be terminated early because the Food and Drug Administration (FDA) unexpectedly recalled the heparin used in the trial due to a possible contamination.\n\nOf the 28 subjects enrolled, limited demographic information is available, and the available data are reported for all subjects as a single group.\n\nOf the 28 subjects enrolled, there were 18 evaluable full-crossover subjects for the statistical analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event (AE) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 24 hours post-last dose of placebo or study drug Serious Adverse Event (SAE) and All-Cause Mortality (ACM) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 30 days post-last dose of placebo or study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Inclusive of all AEs following placebo dose exposures.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 8, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'URG101', 'description': 'Inclusive of all AEs following URG101 (study drug) dose exposures.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 21, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Total', 'description': 'Inclusive of all AEs following all placebo and URG101 dose exposures.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Discomfort/Pain/Burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral Pain/Burn/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Vaginal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Daytime Bladder Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.'}, {'id': 'OG001', 'title': 'URG101', 'description': 'Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.73', 'groupId': 'OG000', 'lowerLimit': '5.04', 'upperLimit': '36.41'}, {'value': '41.86', 'groupId': 'OG001', 'lowerLimit': '27.64', 'upperLimit': '56.08'}]}]}], 'analyses': [{'pValue': '0.0363', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.14', 'ciLowerLimit': '-44.43', 'ciUpperLimit': '2.16', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A paired student t comparison was used to assess treatment differences as measured by 11 point numerical rating scale.'}], 'paramType': 'MEAN', 'timeFrame': 'Through 12 hours', 'description': 'A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.', 'unitOfMeasure': 'Percentage of pain scale change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.'}, {'type': 'SECONDARY', 'title': 'Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.'}, {'id': 'OG001', 'title': 'URG101', 'description': 'Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 12 hours', 'description': "Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.'}, {'type': 'SECONDARY', 'title': 'Change in Total Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.'}, {'id': 'OG001', 'title': 'URG101', 'description': 'Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.04', 'spread': '29.87', 'groupId': 'OG000'}, {'value': '38.31', 'spread': '27.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 12 hours', 'description': "A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.", 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.'}, {'type': 'SECONDARY', 'title': 'Change in Daytime Urinary Urgency Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.'}, {'id': 'OG001', 'title': 'URG101', 'description': 'Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.30', 'spread': '30.53', 'groupId': 'OG000'}, {'value': '34.50', 'spread': '30.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 12 hours', 'description': "A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.", 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.'}, {'type': 'POST_HOC', 'title': 'Determination of Serum Lidocaine Levels Post Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Evaluable URG101 Subjects', 'description': 'Subjects who received at least one dose of URG101 and met protocol and statistical analysis plan criteria to be deemed evaluable.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post-dose', 'description': 'Single-timepoint serum lidocaine measure at one hour following intravesical study drug administration', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of URG101 and met protocol and statistical analysis plan criteria to be deemed evaluable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Crossover Group 1', 'description': 'Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2\n\nURG101: Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.\n\nPlacebo: Liquid formulation without active URG101 drug components'}, {'id': 'FG001', 'title': 'Crossover Group 2', 'description': 'URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2\n\nURG101: Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.\n\nPlacebo: Liquid formulation without active URG101 drug components'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 28 participants received at least one dose in both Crossover Group 1 and Crossover Group 2. A third arm, All Dosed Subjects, has been listed to the Participant Flow section to allow for overall study Baseline Characteristics to be entered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants Dosed', 'description': 'Includes all participants who received at least one dose of URG101 or Placebo\n\n(Placebo: Liquid formulation without active URG101 drug)'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥18 years of age', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects randomized per crossover arm as of the time of study termination.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'dispFirstSubmitDate': '2018-10-09', 'completionDateStruct': {'date': '2008-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2007-08-15', 'dispFirstSubmitQcDate': '2018-10-09', 'resultsFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2007-08-15', 'dispFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-20', 'studyFirstPostDateStruct': {'date': '2007-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Daytime Bladder Pain Intensity', 'timeFrame': 'Through 12 hours', 'description': 'A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire', 'timeFrame': 'Through 12 hours', 'description': "Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement)."}, {'measure': 'Change in Total Symptom Score', 'timeFrame': 'Through 12 hours', 'description': "A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'."}, {'measure': 'Change in Daytime Urinary Urgency Score', 'timeFrame': 'Through 12 hours', 'description': "A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bladder', 'pain', 'urgency', 'frequency'], 'conditions': ['Painful Bladder Syndrome', 'Interstitial Cystitis', 'Bladder Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '22082303', 'type': 'BACKGROUND', 'citation': 'Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female subjects \\>= 18 years of age\n* moderate to severe symptoms of PBS/IC\n* minimum pain/urgency/frequency scores\n* female subjects on hormone therapy must be on stable dose for \\>= 3 months\n\nExclusion Criteria:\n\n* positive pregnancy test or pregnant or lactating\n* narcotics or medical marijuana within 3 months\n* use of any investigational drug or device within 30 days\n* bacterial cystitis within 30 days'}, 'identificationModule': {'nctId': 'NCT00517868', 'briefTitle': 'Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Urigen'}, 'officialTitle': 'URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.', 'orgStudyIdInfo': {'id': 'URG101-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Crossover', 'description': 'Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2', 'interventionNames': ['Drug: URG101', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Crossover 2', 'description': 'URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2', 'interventionNames': ['Drug: URG101', 'Drug: Placebo']}], 'interventions': [{'name': 'URG101', 'type': 'DRUG', 'description': 'Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.', 'armGroupLabels': ['Crossover', 'Crossover 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Liquid formulation without active URG101 drug components', 'armGroupLabels': ['Crossover', 'Crossover 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91741', 'city': 'Glendora', 'state': 'California', 'country': 'United States', 'facility': 'Citrus Valley Medical Research', 'geoPoint': {'lat': 34.13612, 'lon': -117.86534}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'SD Uro-Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic Medical Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30120', 'city': 'Cartersville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Urology', 'geoPoint': {'lat': 34.16533, 'lon': -84.80231}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio Research, P.A.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Jeff Proctor, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia Urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urigen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}