Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 5:18 PM
Study NCT ID:
NCT06810167
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Tenapanor as a Treatment of CF-related Constipation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599417', 'term': 'tenapanor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in SBM frequency', 'timeFrame': 'Patients will record SBM frequency over the 4-week treatment period.', 'description': 'There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.'}], 'secondaryOutcomes': [{'measure': 'Change in PAC-SYM questionnaire score', 'timeFrame': 'Patients will complete the PAC-SYM at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.', 'description': 'There will be a change (with use of descriptive statistics) in bowel symptoms characterized by the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire with tenapanor administration. PAC-SYM is a PRO previously used to examine constipation in pwCF. A decreased score corresponds to improvement of bowel symptoms.'}, {'measure': 'Change in PAC-QOL questionnaire score', 'timeFrame': 'Patients will complete the PAC-QOL at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.', 'description': 'There will be a change (with use of descriptive statistics) in bowel symptoms characterized by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire with tenapanor administration. PAC-QOL is a PRO previously used to examine constipation in pwCF. A decreased score corresponds to improvement of bowel symptoms.'}, {'measure': 'Change in IBS-SSS questionnaire score', 'timeFrame': 'Patients will complete the IBS-SSS at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.', 'description': 'There will be a 50-point change in the Irritable Bowel Syndrome Scoring System - IBS-SSS (in line with recent bowel distress related literature Ford AC, Wright-Hughes A, Alderson SLet al Lancet 2023) in pwCF and CFrC receiving tenapanor.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Constipation', 'Cystic Fibrosis', 'CFrC'], 'conditions': ['Cystic Fibrosis', 'Constipation']}, 'descriptionModule': {'briefSummary': 'Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)\n2. Meeting criteria for CFrC\n\n Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior:\n * Straining in at least 25% of defecations\n * Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)\n * Sensation of incomplete evacuation more than 25% of defecations\n * Sensation of anorectal obstruction/blockage more than 25% of defecations\n * Manual disimpaction/manipulation of pelvic floor to facilitate more than 25% of defecations\n * Fewer than 3 spontaneous bowel movements weekly (change in stool frequency)\n * Loose stools rarely present without the use of laxatives\n3. Willingness to avoid major dietary or lifestyle changes during study.\n\nExclusion Criteria:\n\n1. Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is to be allowed)\n2. Inability to discontinue standing bowel regimen (including fiber, stool softener, as well as either osmotic or stimulant laxative, pro-kinetic serotonergic agents, or other therapy) 2-weeks prior to study drug initiation (with ability to use osmotic laxative therapy as rescue therapy only).\n3. Severe CFrC as determined by study team\n4. Prior tenapanor usage\n5. Hospitalization within 4-weeks prior to study initiation.\n6. DIOS within 4-weeks prior to study initiation.\n7. Other known/suspected mechanical obstruction'}, 'identificationModule': {'nctId': 'NCT06810167', 'briefTitle': 'Assessing Tenapanor as a Treatment of CF-related Constipation.', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.', 'orgStudyIdInfo': {'id': '2024P002058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cystic fibrosis patients with CF-related constipation', 'interventionNames': ['Drug: Tenapanor']}], 'interventions': [{'name': 'Tenapanor', 'type': 'DRUG', 'description': 'CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.', 'armGroupLabels': ['Cystic fibrosis patients with CF-related constipation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chloe Butzel, BA', 'role': 'CONTACT', 'email': 'cbutzel@mgh.harvard.edu', 'phone': '6176437088'}, {'name': 'Christopher Velez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Chloe Butzel, BA', 'role': 'CONTACT', 'email': 'cbutzel@mgh.harvard.edu', 'phone': '6176437088'}], 'overallOfficials': [{'name': 'Christoher D Velez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ardelyx', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Velez', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}