Actively Recruiting
Assessing Tenapanor as a Treatment of CF-related Constipation.
Led by Massachusetts General Hospital · Updated on 2026-03-18
25
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
Ardelyx
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Meets criteria for cystic fibrosis-related constipation (CFrC) with at least two of the following symptoms for at least 3 months and symptom onset at least 6 months prior: straining in 25% or more of bowel movements, Bristol Stool Scale 1-2 in 25% or more of bowel movements, sensation of incomplete evacuation in 25% or more of bowel movements, sensation of anorectal blockage in 25% or more of bowel movements, manual disimpaction/manipulation in 25% or more of bowel movements, fewer than 3 spontaneous bowel movements weekly, and rarely loose stools without laxatives
- 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 for lung function)
- Inability to stop standing bowel regimen 2 weeks before starting study drug (except osmotic laxatives as rescue therapy only)
- Severe cystic fibrosis-related constipation as determined by the study team
- Prior use of tenapanor
- Hospitalization within 4 weeks prior to study start
- Distal intestinal obstruction syndrome (DIOS) within 4 weeks prior to study start
- Known or suspected mechanical bowel obstruction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
C
Chloe Butzel, BA
CONTACT
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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