NCT06810167 Assessing Tenapanor as a Treatment of CF-related Constipation.
| NCT ID | NCT06810167 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Massachusetts General Hospital |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 25 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Christoher D Velez, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06810167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06810167 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 25 participants.
Is NCT06810167 currently recruiting?
Yes, NCT06810167 is actively recruiting participants. Contact the research team at cbutzel@mgh.harvard.edu for enrollment information.
Where is the NCT06810167 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06810167 clinical trial?
NCT06810167 is sponsored by Massachusetts General Hospital. The principal investigator is Christoher D Velez, MD at Massachusetts General Hospital. The trial plans to enroll 25 participants.