Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT01900704
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2013-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
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': {'description': 'Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily', 'otherNumAtRisk': 266, 'otherNumAffected': 30, 'seriousNumAtRisk': 266, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'SER120 1500 ng', 'description': 'All participants received SER120 1500 ng once daily', 'otherNumAtRisk': 264, 'otherNumAffected': 30, 'seriousNumAtRisk': 264, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'All participants received Placebo once daily', 'otherNumAtRisk': 267, 'otherNumAffected': 30, 'seriousNumAtRisk': 267, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Salivary gland cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily'}, {'id': 'OG001', 'title': 'SER120 1500 ng', 'description': 'All participants received SER120 1500 ng once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'All participants received Placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12', 'unitOfMeasure': 'nocturic episodes per night', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population'}, {'type': 'PRIMARY', 'title': 'Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily'}, {'id': 'OG001', 'title': 'SER120 1500 ng', 'description': 'All participant received SER120 1500 ng once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'All participants received Placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SER120 1500 ng', 'description': 'All participants received SER120 1500 ng once daily'}, {'id': 'FG001', 'title': 'SER120 750 ng', 'description': 'All participant received SER120 750 ng once daily'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'All participants received Placebo once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '270'}, {'groupId': 'FG002', 'numSubjects': '270'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '235'}, {'groupId': 'FG002', 'numSubjects': '237'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}, {'value': '782', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily'}, {'id': 'BG001', 'title': 'SER120 1500 ng', 'description': 'All participants received SER120 1500 ng once daily'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'All participants received Placebo once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '66.1', 'spread': '9.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '438', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}, {'value': '661', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}, {'value': '734', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-To-Treat Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 810}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2015-11-23', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2013-07-12', 'dispFirstSubmitQcDate': '2015-11-23', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2013-07-15', 'dispFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-06', 'studyFirstPostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment', 'timeFrame': '12 weeks', 'description': 'Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12'}, {'measure': 'Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes', 'timeFrame': '12 weeks', 'description': 'Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nocturia']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', '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 greater than 2 nocturic episodes per night\n\nExclusion Criteria:\n\n* CHF\n* Diabetis Insipidus\n* Renal insufficiency\n* Hepatic insufficiency\n* Incontinence\n* Illnesses requiring systemic steroids\n* Malignancy within the past 5 years\n* Sleep apnea\n* Nephrotic syndrome\n* Unexplained pelvic mass\n* Urinary bladder neurological dysfunction\n* Urinary bladder surgery or radiotherapy\n* Pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01900704', 'acronym': 'DB4', 'briefTitle': 'Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4', 'organization': {'class': 'INDUSTRY', 'fullName': 'Serenity Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia', 'orgStudyIdInfo': {'id': 'SPC-SER120-DB4-201301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SER120 750 ng', 'description': 'SER120 750 ng', 'interventionNames': ['Drug: SER120 750 ng']}, {'type': 'EXPERIMENTAL', 'label': 'SER120 1500 ng', 'description': 'SER120 1500 ng', 'interventionNames': ['Drug: SER120 1500 ng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SER120 750 ng', 'type': 'DRUG', 'description': 'SER120 750 ng', 'armGroupLabels': ['SER120 750 ng']}, {'name': 'SER120 1500 ng', 'type': 'DRUG', 'description': 'SER120 1500 ng', 'armGroupLabels': ['SER120 1500 ng']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Stephen M. Auerbach, MD', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serenity Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}