Study of Tenapanor for Treating Constipation Related to Cystic Fibrosis Open-label, Single Center Phase 3 Trial in Adults with CF

What this Trial Is About

Researchers are evaluating tenapanor, a recently FDA-approved drug for irritable bowel syndrome with constipation, as a treatment for constipation related to cystic fibrosis CFrC in patients with cystic fibrosis. This phase 3, open-label study aims to understand how tenapanor affects bowel movement frequency and gastrointestinal symptoms in this population. The study is sponsored by Massachusetts General Hospital and focuses on patients aged 18 to 75 years. Participants will take one 50 mg tablet of tenapanor twice daily for four weeks. During this treatment period, they will complete three questionnairesthe PAC-SYM, PAC-QoL, and IBS-SSSat multiple time points before and during treatment to assess symptom severity and quality of life. They will also keep daily diaries to track spontaneous bowel movement frequency and gastrointestinal symptom burden. Throughout the study, patients will record their bowel movements daily over the four-week treatment. Questionnaires will be completed at two weeks before starting, at the start, two weeks into treatment, and at the end of the four weeks. Researchers will monitor changes in bowel movement frequency and symptom scores to evaluate the impact of tenapanor. The total participation lasts for about six weeks, including the pre-treatment assessments and the treatment period.

Assessing Tenapanor as a Treatment of CF-related Constipation.