Assessing Tenapanor as a Treatment of CF-related Constipation.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMassachusetts General Hospital
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 characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.
Eligibility criteria
Qualifiers
Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
Meeting criteria for CFrC
Straining in at least 25% of defecations
Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)
Disqualifiers
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).
Severe CFrC as determined by study team
Prior tenapanor usage
Trial design
Treatments tested in this trial
- Tenapanor
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Ardelyx
Collaborator
Source ClinicalTrials.gov