Assessing Tenapanor as a Treatment of CF-related Constipation.

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tenapanor to see if it can help patients with cystic fibrosis (CF) who also experience constipation related to their condition. Tenapanor is already approved for treating a different type of constipation, but this study aims to find out if it can work for those with CF-related constipation. Participants in the trial will take one 50 mg tablet of tenapanor twice a day for four weeks. Throughout the study, they will fill out questionnaires and keep daily diaries to track their digestive symptoms and how often they have bowel movements.

To be eligible for this trial, participants must have a confirmed diagnosis of cystic fibrosis and experience specific symptoms of constipation for at least three months. These symptoms may include difficulty passing stools, feeling like they can’t completely empty their bowels, or having fewer than three bowel movements a week. They also need to avoid making major changes to their diet or lifestyle during the study. This trial is not yet recruiting participants, but it will include individuals of all genders aged between 6 and 17 years. It's important for potential participants to note that they cannot have used certain medications or had specific complications within a few weeks prior to joining the study.

Gender

ALL

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 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
• • 3. Willingness to avoid major dietary or lifestyle changes during study.
• Exclusion Criteria:
• • 1. 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)
• • 2. 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).
• • 3. Severe CFrC as determined by study team
• • 4. Prior tenapanor usage
• • 5. Hospitalization within 4-weeks prior to study initiation.
• • 6. DIOS within 4-weeks prior to study initiation.
• • 7. Other known/suspected mechanical obstruction