Assessing Tenapanor as a Treatment of CF-related Constipation.
Recruiting
Phase 3
Interventional Study
Cystic Fibrosis
Constipation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
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 c…
Trial Locations
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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…
Contacts