A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
A 26-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Chronic Idiopathic Constipation (CIC) in Adults
Ardelyx
692 participants
Jan 13, 2026
INTERVENTIONAL
Conditions
Summary
This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.
Eligibility
Inclusion Criteria8
- Patients ≥18 to ≤80 years old at the Screening visit (Visit 1).
- Meet the Rome IV Diagnostic Criteria for functional constipation.
- Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication.
- Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization.
- Meets the entry criteria assessed during the Screening period.
- Ability to understand and provide input on the assessments in the eDiary.
- Provide written informed consent before the initiation of any study-specific procedures.
- Must agree to have daily access to eDiary via a computer, tablet or smart phone
Exclusion Criteria19
- Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3 months prior to the Screening visit
- Fecal impaction within 6 months prior to the Screening visit
- Unexplained and clinically significant alarm symptoms.
- Functional diarrhea as defined by Rome IV criteria
- IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria
- Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit
- Patient with central nervous system disorder
- Use of prohibited medications defined by protocol
- Patient has a 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, with the exception of cannabis and cannabidiol (CBD)
- Any evidence of or treatment of malignancy within 1 year prior to the Screening visit
- Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit
- Pregnant women or women planning to become pregnant during trial participation
- A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit.
- Alcohol or substance abuse within 1 year prior to the Screening visit
- Participation in other clinical trials within 1 month prior to the Screening visit
- Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial
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Interventions
Patients will receive tenapanor 5 mg BID (total of 10 mg daily)
Patients will receive tenapanor 25 mg BID (total of 50 mg daily)
Patients will receive tenapanor 50 mg BID (total of 100 mg daily)
Patients will receive matching placebo BID
Locations(79)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07382167