[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06810167":3,"trial-entities:NCT06810167":88,"trial-summary:NCT06810167":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":69,"locations":72,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT06810167","2024P002058","Assessing Tenapanor as a Treatment of CF-related Constipation.","An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.","ACTIVE_NOT_RECRUITING","2027-06-30","2026-08","2026-08-21","2025-06-01","Massachusetts General Hospital","OTHER",false,"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.",null,[19,20],"Cystic Fibrosis","Constipation",[20,19,22],"CFrC","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},25,"ACTUAL",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Tenapanor","CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.",[36],"Cystic fibrosis patients with CF-related constipation",[38],{"measure":39,"description":40,"timeFrame":41},"Increase in SBM frequency","There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.","Patients will record SBM frequency over the 4-week treatment period.",[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Change in PAC-SYM questionnaire score","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.","Patients will complete the PAC-SYM at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.",{"measure":48,"description":49,"timeFrame":50},"Change in PAC-QOL questionnaire score","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.","Patients will complete the PAC-QOL at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.",{"measure":52,"description":53,"timeFrame":54},"Change in IBS-SSS questionnaire score","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.","Patients will complete the IBS-SSS at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.","ALL","18 Years","75 Years",{"inclusion":59,"exclusion":67,"raw_text":68},[60,61,62,63,64,65,66],"Straining in at least 25% of defecations","Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)","Sensation of incomplete evacuation more than 25% of defecations","Sensation of anorectal obstruction\u002Fblockage more than 25% of defecations","Manual disimpaction\u002Fmanipulation of pelvic floor to facilitate more than 25% of defecations","Fewer than 3 spontaneous bowel movements weekly (change in stool frequency)","Loose stools rarely present without the use of laxatives 3. Willingness to avoid major dietary or lifestyle changes during study.",[],"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\u002Fblockage more than 25% of defecations\n   * Manual disimpaction\u002Fmanipulation 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\u002Fsuspected mechanical obstruction",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Boston","Massachusetts","02114","United States",{"lat":79,"lon":80},42.35843,-71.05977,[],[83],{"name":84,"affiliation":13,"role":85},"Christoher D Velez, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":90},[20,19],[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study planning to enroll 25 participants. It is not specified if it is randomized or blinded.","completed","Tenapanor for Cystic Fibrosis-Related Constipation","This study is testing a medication called tenapanor to see if it can help people with cystic fibrosis (CF) who also experience constipation related to their CF (CFrC). Tenapanor is already approved for a different type of constipation. If you join, you would take one 50 mg tablet of tenapanor twice a day for four weeks. The study will look at how often you have a bowel movement and how your constipation symptoms change. To be eligible, you need to be between 18 and 75 years old, have confirmed CF, and meet specific criteria for CFrC, such as straining during bowel movements or having certain stool types. The study plans to enroll 25 participants.","The primary outcome, increase in spontaneous bowel movement (SBM) frequency, is measured over the 4-week treatment period.",114,"You would take tenapanor twice daily for 4 weeks. You would also complete three questionnaires and daily diaries to track your symptoms and bowel movements.","Not stated in the trial record.",[33],"v2"]