RECRUITING

Assessing Tenapanor as a Treatment of CF-related Constipation.

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.

Quick Facts

Study Start:2025-06-01

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06810167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing) 2. 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) * 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.	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

Inclusion Criteria

Exclusion Criteria

1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
2. 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)
* 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.

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

Contacts and Locations

Study Contact

Chloe Butzel, BA

CONTACT

6176437088

cbutzel@mgh.harvard.edu

Principal Investigator

Christoher D Velez, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Christoher D Velez, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

Constipation
Cystic Fibrosis
CFrC

Additional Relevant MeSH Terms

Cystic Fibrosis
Constipation