NCT06810167Active, not recruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 23 Jan 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Cystic fibrosis
- NCT number
- NCT06810167
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 25
- From 1 Jun 2025 to the primary completion date, 15 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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).
- Prior tenapanor usage
- Hospitalization within 4-weeks prior to study initiation.
- DIOS within 4-weeks prior to study initiation.
Other
- Severe CFrC as determined by study team
- Other known/suspected mechanical obstruction
Who the study is looking for
- Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
- 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
- Willingness to avoid major dietary or lifestyle changes during study.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.