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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.

Study design
This is an interventional study planning to enroll 25 participants. It is not specified if it is randomized or blinded.
What's involved
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.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, increase in spontaneous bowel movement (SBM) frequency, is measured over the 4-week treatment period.

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NCT06810167

Assessing Tenapanor as a Treatment of CF-related Constipation.

Active, Not Recruiting
PHASE3Ages 18–75InterventionalTreatment
Massachusetts General Hospital
~25 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Tenapanor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Increase in SBM frequency
Measured over Patients will record SBM frequency over the 4-week treatment period.

Conditions

Cystic Fibrosis
Constipation

Explore related trials

ConstipationCystic Fibrosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Christoher D Velez, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Increase in SBM frequencyPatients will record SBM frequency over the 4-week treatment period.

    There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.