Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-07 @ 12:06 AM
Study NCT ID:
NCT02727751
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2016-03-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599417', 'term': 'tenapanor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drosenbaum@ardelyx.com', 'phone': '5107451752', 'title': 'Chief Development Officer', 'organization': 'Ardelyx'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'This was an extension study that ran for up to 1 year', 'eventGroups': [{'id': 'EG000', 'title': '50mg BID', 'description': 'Tenapanor, 50 mg BID (100 mg total)', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 33, 'seriousNumAtRisk': 312, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events in >2% Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '50mg BID', 'description': 'Tenapanor, 50 mg BID (100 mg total)'}], 'classes': [{'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Upper Respiratory Tract Infection', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52-55 weeks', 'description': 'Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50mg BID', 'description': 'Tenapanor, 50 mg BID (100 mg total)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '312'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '50mg BID', 'description': 'Tenapanor, 50 mg BID (100 mg total)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '13.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '255', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '130', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '182', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '217', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.98', 'spread': '6.707', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-29', 'size': 460787, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-10T13:54', 'hasProtocol': True}, {'date': '2016-03-08', 'size': 314048, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-10T13:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2016-03-23', 'resultsFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-10', 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events in >2% Patients', 'timeFrame': '52-55 weeks', 'description': 'Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Constipation Predominant Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '37668173', 'type': 'DERIVED', 'citation': 'Lembo AJ, Friedenberg KA, Fogel RP, Edelstein S, Zhao S, Yang Y, Rosenbaum DP, Chey WD. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023 Nov;35(11):e14658. doi: 10.1111/nmo.14658. Epub 2023 Sep 5.'}, {'pmid': '33337659', 'type': 'DERIVED', 'citation': 'Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.'}]}, 'descriptionModule': {'briefSummary': 'This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.', 'detailedDescription': 'During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302\n* Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies\n* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception\n* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization\n\nExclusion Criteria:\n\n* Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302\n* The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT02727751', 'acronym': 'T3MPO-3', 'briefTitle': 'A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardelyx'}, 'officialTitle': 'An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)', 'orgStudyIdInfo': {'id': 'TEN-01-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50mg BID', 'description': 'Tenapanor, 50 mg BID (100 mg total)', 'interventionNames': ['Drug: Tenapanor']}], 'interventions': [{'name': 'Tenapanor', 'type': 'DRUG', 'otherNames': ['RDX5791', 'AZD1722'], 'armGroupLabels': ['50mg BID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ardelyx Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'David P Rosenbaum, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ardelyx, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardelyx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}