Actively Recruiting
A 26-Week Study of Tenapanor Taken Twice Daily to Treat Adults With Chronic Idiopathic Constipation
Led by Ardelyx · Updated on 2026-06-04
692
Participants Needed
109
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.
CONDITIONS
Brief Title
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years at the Screening visit
- Meet the Rome IV Diagnostic Criteria for functional constipation
- Females of non-childbearing potential or agree to use contraception for 30 days after last dose
- Males must use barrier contraception or have documented surgical sterilization
- Meet entry criteria assessed during Screening
- Able to understand and provide input on electronic diary assessments
- Provide written informed consent before study procedures
- Agree to have daily access to electronic diary via computer, tablet, or smartphone
You will not qualify if you...
- Loose or watery stool without medication affecting stool consistency for more than 25% of bowel movements in the 3 months before Screening
- Fecal impaction within 6 months before Screening
- Unexplained, significant alarm symptoms
- Functional diarrhea as per Rome IV criteria
- IBS with constipation, diarrhea, mixed, or unsubtyped IBS per Rome IV
- Diagnosis or treatment of symptomatic GI abnormalities or active disease within 6 months before Screening
- Central nervous system disorder
- Use of prohibited medications per protocol
- History or current evidence of laxative abuse
- Hepatic dysfunction
- Positive HIV, hepatitis B, or hepatitis C test at Screening
- Positive urinary drug test at Screening except cannabis or cannabidiol
- Malignancy treatment or evidence within 1 year before Screening
- Surgery on stomach, small intestine, or colon within 60 days before Screening (except appendectomy or cholecystectomy)
- Pregnant or planning pregnancy during trial
- Major psychiatric disorder requiring hospitalization in last year
- Alcohol or substance abuse within 1 year before Screening
- Participation in other trials within 1 month before Screening
- Significant disease interfering with study completion
Research Team
M
Marica Tambongco
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