Assessing Tenapanor as a Treatment of CF-related Constipation.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06810167
Phase
PHASE3
Status
Recruiting
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Conditions

  • Constipation
  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tenapanor — DRUG
    CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cystic fibrosis patients with CF-related constipation

Primary Outcome Measure

Increase in SBM frequency [ Time Frame: Patients will record SBM frequency over the 4-week treatment period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Chloe Butzel, BA
[email protected]
6176437088
Christopher Velez, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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