An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.
Massachusetts General Hospital
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 fa…
Interventions
- DrugTenapanor
CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.
Location
- Massachusetts General HospitalBoston, Massachusetts