Assessing Tenapanor as a Treatment of CF-related Constipation.

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Massachusetts General Hospital
Sponsor
Massachusetts General Hospital
Information Provided by (Responsible Party)
Christopher Velez
Clinicaltrials.gov Identifier
NCT06810167
Other Study ID Numbers:
2024P002058
First Submitted
January 22, 2025
First Posted
February 4, 2025
Last Update Posted
March 17, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Cystic FibrosisConstipation
Drug: Tenapanor

Study Design

Study TypeInterventional
Actual Enrollment25 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.
Study Start DateMay 31, 2025
Actual Primary Completion Date1mo 2w from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Cystic fibrosis patients with CF-related constipation
Drug: Tenapanor
CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing) 2. Meeting criteria for CFrC Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior:
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/blockage more than 25% of defecations
Manual disimpaction/manipulation 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.
Exclusion Criteria
1. 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) 2. 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). 3. Severe CFrC as determined by study team 4. Prior tenapanor usage 5. Hospitalization within 4-weeks prior to study initiation. 6. DIOS within 4-weeks prior to study initiation. 7. Other known/suspected mechanical obstruction

Contacts and Locations

Sponsors and CollaboratorsMassachusetts General Hospital
Locations
Massachusetts General Hospital | Boston Massachusetts, United States, 02114
Investigators
Principal Investigator: Christoher D Velez, MD, Massachusetts General Hospital