Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00410735
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2006-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of ONO-1078 in Patients With Chronic Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 495}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2006-12-12', 'studyFirstSubmitQcDate': '2006-12-12', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nasal congestion', 'timeFrame': '12 weeks'}, {'measure': 'rhinorrhea', 'timeFrame': '12 weeks'}, {'measure': 'postnasal drip', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'easiness of blowing nose', 'timeFrame': '12 weeks'}, {'measure': 'easiness of removing postnasal drip', 'timeFrame': '12 weeks'}, {'measure': 'dull headache', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['ONO-1078', 'chronic sinusitis'], 'conditions': ['Chronic Sinusitis']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic sinusitis\n\nExclusion Criteria:\n\n* acute sinusitis\n* chronic sinusitis with acute exacerbation'}, 'identificationModule': {'nctId': 'NCT00410735', 'briefTitle': 'Study of ONO-1078 in Patients With Chronic Sinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study', 'orgStudyIdInfo': {'id': 'ONO-1078-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'interventionNames': ['Drug: Pranlukast hydrate']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '0 mg BID for 12 weeks', 'armGroupLabels': ['P']}, {'name': 'Pranlukast hydrate', 'type': 'DRUG', 'description': '225 mg BID for 12 weeks', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'country': 'Japan', 'facility': 'Chubu region', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokuriku', 'country': 'Japan', 'facility': 'Hokuriku region'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Kanto region'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Kinki region'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Kyushu region'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku region', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Hajime Yamamotoya', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}