Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04746105
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723815', 'term': 'TS-142'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least square mean difference of Apnea hypopnea index (AHI) from placebo', 'timeFrame': 'Day 1', 'description': 'AHI is a number of apnea and hypopnea events per hour during sleep determined by polysoćography (PSG).'}], 'secondaryOutcomes': [{'measure': 'Least square mean difference of the mean SpO2 in total sleep time from placebo', 'timeFrame': 'Day 1', 'description': 'The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients with Mild Obstructive Sleep Apnea Hypopnea']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese male and female, age 20 years or older at the time of informed consent\n* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from this study:\n\n* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder\n* Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea\n* Patients with percutaneous arterial oxygen saturation (SpO2) \\<94% by pulse oximetry at visit 1\n* Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT04746105', 'briefTitle': 'A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Study to Evaluate the Respiratory Safety of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.', 'orgStudyIdInfo': {'id': 'TS142-208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TS-142', 'description': 'Period in which subjects received TS-142 10 mg or The night when subjects received TS-142', 'interventionNames': ['Drug: TS-142']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Period in which subjects received placebo or The night when subjects received matched placebo', 'interventionNames': ['Drug: Dose-matched Placebo to TS-142']}], 'interventions': [{'name': 'TS-142', 'type': 'DRUG', 'description': 'Subjects received single-dose of 10 mg of TS-142 (oral tablet)', 'armGroupLabels': ['TS-142']}, {'name': 'Dose-matched Placebo to TS-142', 'type': 'DRUG', 'description': 'Subjects received single-dose matched placebo to TS-142 (oral tablet)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Taisho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Taisho Direcoter', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taisho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}