NCT06810167

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Constipation

Interventions

Type	Name	Description
DRUG	Tenapanor	CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-02-05
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study