Assessing Tenapanor as a Treatment of CF-related Constipation.

Korábbi kezelés

• 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).
• Prior tenapanor usage
• Hospitalization within 4-weeks prior to study initiation.
• DIOS within 4-weeks prior to study initiation.

Egyéb

• Severe CFrC as determined by study team
• Other known/suspected mechanical obstruction

• Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
• 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
• Willingness to avoid major dietary or lifestyle changes during study.