Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 6:37 AM
Study NCT ID:
NCT04861233
Status:
UNKNOWN
Last Update Posted:
2022-11-17
First Post:
2021-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lubiprostone to Treat Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Adverse Events (AEs)', 'timeFrame': 'Up to 12 months', 'description': 'AEs is defined as any undesirable and unintended signs (example, abnormal laboratory values), symptoms, or diseases which occur during or following the administration of the drug, this does not necessarily require causal relationship.'}, {'measure': 'Number of Participants Reporting One or More Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 12 months', 'description': 'A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Frequency of Spontaneous Bowel Movement (SBM) at End of Treatment', 'timeFrame': 'Baseline up to end of treatment (approximately 12 months)', 'description': 'SBM is a bowel movement occurring in the absence of laxative use. Change from baseline values will be reported for participants who discontinue lubiprostone during study period.'}, {'measure': 'Time to Resolution of Symptoms After Treatment Discontinuation', 'timeFrame': 'Up to 12 months', 'description': 'Time to resolution of symptoms defined as discontinuation of treatment with lubiprostone.'}, {'measure': 'Change From Baseline in Frequency of SBM After 12-month Follow up', 'timeFrame': 'Up to 12 months', 'description': 'SBM is a bowel movement occurring in the absence of laxative use. Change from baseline values after 12-months follow up period will be reported for participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Constipation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/608c06ad688ad8001f42fbc0', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': "The main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic's standard practice.", 'detailedDescription': 'This is a prospective, observational post-marketing surveillance study of lubiprostone in participants with constipation. The study will assess the safety and effectiveness of lubiprostone for its approved indication with real-world setting in South Korea.\n\nThe study will enroll approximately 3000 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:\n\n• All Participants\n\nThe study will be conducted in South Korea. The overall duration of the study will be approximately 6 years. Data collection will be based on routinely scheduled visits during a 12-month follow up period for each participant up to a final follow-up when the participant discontinues treatment or at the end of follow-up period for any participants still taking lubiprostone.\n\nNOTE: This product was divested from Takeda to Jeil in 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants with first incident prescription for treatment with lubiprostone will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. South Korean adult.\n2. With constipation caused by:\n\n * Chronic Idiopathic Constipation (CIC), or\n * Opioid-Induced Constipation (OIC) from treatment for chronic, non-cancer pain, including participants with chronic pain related to prior cancer or its treatment who do not require frequent (example weekly) opioid dosage escalation.\n3. Is newly prescribed (first incident) and initiates lubiprostone for the treatment of constipation.\n\nExclusion Criteria:\n\n1. Treated with lubiprostone outside of the locally approved label in South Korea.\n2. Participating in any other clinical study investigating one (or more) of the approved indications of lubiprostone.'}, 'identificationModule': {'nctId': 'NCT04861233', 'briefTitle': 'A Study of Lubiprostone to Treat Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jeil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea', 'orgStudyIdInfo': {'id': 'JL-PMS-AM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Participants diagnosed with constipation who have been prescribed with lubiprostone for the first time in a real-world setting will be observed prospectively and followed up for 12 months after initiation of study medication. Treatment regimen, frequency of laboratory and clinical assessments will be determined by investigator in a routine clinical practice.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is a non-interventional study.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10326', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'drlimyj@gmail.com', 'phone': '+82-31-961-7730'}, {'name': 'Yun Jeong Lim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Yun Jeong Lim, M.D Ph.D', 'role': 'CONTACT', 'email': 'drlimyj@gmail.com', 'phone': '+82-31-961-7730'}], 'overallOfficials': [{'name': 'Site Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jeil Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}