Tenapanor for Cystic Fibrosis-Related Constipation

Overseen By Chloe Butzel, BA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Must not be taking: Antibiotics, Laxatives

Disqualifiers: Severe CFrC, DIOS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Christoher D Velez, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for cystic fibrosis patients who have constipation. They must have confirmed cystic fibrosis, meet criteria for CF-related constipation like straining or feeling of incomplete bowel evacuation, and have fewer than three spontaneous bowel movements weekly. Participants should not plan major dietary or lifestyle changes during the study.

Inclusion Criteria

I have less than 3 bowel movements a week.

I rarely have loose stools without taking laxatives.

I meet the criteria for CFrC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive tenapanor, 50 mg tablet twice daily, for a 4-week treatment period

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tenapanor

Trial Overview The trial tests Tenapanor, an FDA-approved drug for IBS with constipation, to treat cystic fibrosis-related constipation (CFrC). Patients will take a 50 mg tablet twice daily for four weeks and complete questionnaires and diaries about their gastrointestinal symptoms and bowel movement frequency.

How Is the Trial Designed?

Group I: Cystic fibrosis patients with CF-related constipation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Ardelyx

Industry Sponsor

Trials

31

Recruited

6,100+