Actively Recruiting
An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF
Led by Massachusetts General Hospital · Updated on 2026-03-18
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
Ardelyx
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating tenapanor, a recently FDA-approved drug for irritable bowel syndrome with constipation, as a treatment for constipation related to cystic fibrosis (CFrC) in patients with cystic fibrosis. This phase 3, open-label study aims to understand how tenapanor affects bowel movement frequency and gastrointestinal symptoms in this population. The study is sponsored by Massachusetts General Hospital and focuses on patients aged 18 to 75 years. Participants will take one 50 mg tablet of tenapanor twice daily for four weeks. During this treatment period, they will complete three questionnaires—the PAC-SYM, PAC-QoL, and IBS-SSS—at multiple time points before and during treatment to assess symptom severity and quality of life. They will also keep daily diaries to track spontaneous bowel movement frequency and gastrointestinal symptom burden. Throughout the study, patients will record their bowel movements daily over the four-week treatment. Questionnaires will be completed at two weeks before starting, at the start, two weeks into treatment, and at the end of the four weeks. Researchers will monitor changes in bowel movement frequency and symptom scores to evaluate the impact of tenapanor. The total participation lasts for about six weeks, including the pre-treatment assessments and the treatment period.
CONDITIONS
Brief Title
Assessing Tenapanor as a Treatment of CF-related Constipation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cystic fibrosis by sweat chloride or genetic testing
- Meet criteria for cystic fibrosis-related constipation with at least 2 symptoms such as straining, hard stools, incomplete evacuation, anorectal blockage sensation, manual disimpaction, fewer than 3 spontaneous bowel movements per week, or rare loose stools without laxatives
- Symptoms present for at least 3 months with onset at least 6 months prior
- Willingness to avoid major dietary or lifestyle changes during the study
You will not qualify if you...
- Use of any antibiotic to treat infection within 4 weeks prior to study start (except stable azithromycin dosed 3 times weekly)
- Inability to stop standing bowel regimen 2 weeks before starting study drug (except rescue osmotic laxatives allowed)
- Severe cystic fibrosis-related constipation as determined by study team
- Prior use of tenapanor
- Hospitalization within 4 weeks prior to study start
- Distal intestinal obstruction syndrome within 4 weeks prior to study start
- Known or suspected mechanical bowel obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants ingest one 50 mg tablet of tenapanor twice daily for 4 weeks to treat CF-related constipation.
Visits at baseline, 2 weeks, and 4 weeks for assessments
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
C
Chloe Butzel, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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