Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-21 @ 12:30 AM
Study NCT ID:
NCT00937859
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Patients With Nocturia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sfein@serenitypharma.com', 'phone': '8456396760', 'title': 'Chief Medical Officer', 'phoneExt': '17', 'organization': 'Serenity Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SER120', 'description': 'All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.', 'otherNumAtRisk': 148, 'otherNumAffected': 105, 'seriousNumAtRisk': 148, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.', 'otherNumAtRisk': 153, 'otherNumAffected': 108, 'seriousNumAtRisk': 153, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 58, 'numAffected': 58}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post nasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Number of Nocturic Episodes/Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SER120', 'description': 'All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7 weeks', 'description': 'Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline', 'unitOfMeasure': 'nocturic episodes per night', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'PRIMARY', 'title': 'Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SER120', 'description': 'All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 weeks', 'description': 'Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SER120', 'description': 'All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SER120', 'description': 'All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-treat'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'dispFirstSubmitDate': '2013-12-19', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2009-07-09', 'dispFirstSubmitQcDate': '2014-01-27', 'resultsFirstSubmitDate': '2020-08-28', 'studyFirstSubmitQcDate': '2009-07-10', 'dispFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-28', 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Number of Nocturic Episodes/Night', 'timeFrame': '7 weeks', 'description': 'Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline'}, {'measure': 'Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night', 'timeFrame': '7 weeks', 'description': 'Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nocturia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female 50 years or older\n* Nocturia of 6 or more months duration averaging 2 episodes or more per night\n\nExclusion Criteria:\n\n* CHF\n* Diabetes\n* Diabetes Insipidus\n* Renal Insufficiency\n* Hepatic Insufficiency\n* Incontinence\n* Illness requiring steroids\n* Current or past urologic malignancy\n* Nephrotic Syndrome\n* Unexplained pelvic masses\n* Urinary bladder neurological dysfunction\n* Urinary bladder surgery or radiotherapy\n* Sleep Apnea\n* Pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT00937859', 'briefTitle': 'Treatment of Patients With Nocturia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Serenity Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia', 'orgStudyIdInfo': {'id': 'SPC-SER120-DB1-200901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SER120', 'description': 'SER120', 'interventionNames': ['Drug: SER120']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SER120', 'type': 'DRUG', 'description': 'SER120', 'armGroupLabels': ['SER120']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Medical Research Assoc.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serenity Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}