Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-31 @ 5:13 AM
Study NCT ID:
NCT06752603
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2024-12-22', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weekly mean of average pain score from baseline to Week 12 of the treatment period', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 20 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in weekly mean of average pain score from baseline in each week', 'timeFrame': 'Up to 20 weeks'}, {'measure': '30%- and 50%-responder rates based on the weekly mean of average pain score', 'timeFrame': 'Up to 20 weeks', 'description': 'proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively'}, {'measure': 'Change in weekly mean of worst pain score from baseline to each week', 'timeFrame': 'Up to 20 weeks'}, {'measure': '30%- and 50%-responder rates based on the weekly mean of worst pain score', 'timeFrame': 'Up to 20 weeks', 'description': 'proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively'}, {'measure': 'Change in Interstitial cystitis symptom index (ICSI) score from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Interstitial cystitis problem index (ICPI) score from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Average frequency of urination per day from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Frequency of nocturnal urination per day from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Mean volume voided per micturition in a day from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Maximum volume voided per micturition in a day from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Number of urgency episodes per day from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Patient Global Impression of Change (PGIC) score from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in SF-12v2 score from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Change in Hospital Anxiety and Depression Scale (HADS) score from baseline', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Plasma ONO-1110 concentrations', 'timeFrame': 'Up to 20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ONO-1110', 'ONO-1110-06', 'Hunner Type Interstitial Cystitis'], 'conditions': ['Hunner Type Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese (both sexes)\n* Age (at the time of informed consent): 18 years and older\n* Outpatient\n* Patients who are considered capable of understanding the study procedures and completing the pain diary, bladder diary, and questionnaires appropriately by the investigator (sub-investigator）\n* Patients given a diagnosis of HIC by cystoscopy\n* Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria\n\nExclusion Criteria:\n\n* Patients with a history and presence of chemical cystitis\n* Patients with a history of bladder augmentation or radical cystectomy\n* Patients with pain other than HIC that may affect assessments in this study\n* Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study\n* Patients receiving medications for psychiatric disease'}, 'identificationModule': {'nctId': 'NCT06752603', 'briefTitle': 'A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Hunner Type Interstitial Cystitis', 'orgStudyIdInfo': {'id': 'ONO-1110-06'}, 'secondaryIdInfos': [{'id': 'jRCT2031240558', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONO-1110', 'description': 'ONO-1110 tablets once a day', 'interventionNames': ['Drug: ONO-1110']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ONO-1110', 'type': 'DRUG', 'description': 'ONO-1110 tablets once a day', 'armGroupLabels': ['ONO-1110']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nagoya University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Harasanshin Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'state': 'Fukushima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gifu', 'state': 'Gifu', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Japanese Red Cross Gifu Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Takasaki', 'state': 'Gunma', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kurosawa Hospital Health Park Clinic', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Niimura Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kanto Rosai Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kyoto', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Rakuwakai Marutamachi Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Kyoto', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Ueda Clinic', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Izumi Chuo Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Shinshu University Hospital', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Beppu', 'state': 'Oita Prefecture', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nakamura Hospital', 'geoPoint': {'lat': 33.27945, 'lon': 131.49751}}, {'city': 'Okayama', 'state': 'Okayama-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Saga', 'state': 'Saga-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nanri Urological Clinic', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Minato-Ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'The Jikei University Hospital'}, {'city': 'Mitaka', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kyorin University Hospital', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'city': 'Tokyo', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'The University Of Tokyo Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Uozu', 'state': 'Toyama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Toyama Rosai Hospital', 'geoPoint': {'lat': 36.8, 'lon': 137.4}}, {'city': 'Chūō', 'state': 'Yamanashi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University Of Yamanashi Hospital', 'geoPoint': {'lat': 35.59465, 'lon': 138.50275}}, {'city': 'Nagasaki', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nagasaki University Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}], 'centralContacts': [{'name': 'North America Clinical Trial Support Desk', 'role': 'CONTACT', 'email': 'clinical_trial@ono-pharma.com', 'phone': '+18665877745(Toll-Free)'}, {'name': 'International Clinical Trial Support Desk', 'role': 'CONTACT', 'email': 'clinical_trial@ono-pharma.com', 'phone': '+17162141777(Standard)'}], 'overallOfficials': [{'name': 'Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}