RECRUITING

Assessing Tenapanor as a Treatment of CF-related Constipation.

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.

Conditions

Cystic FibrosisConstipation
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Related Conditions:

Cystic FibrosisConstipation

Study Overview

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Study Details

Study overview

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.

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

Assessing Tenapanor as a Treatment of CF-related Constipation.

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Christoher D Velez, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2027-06-30