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26-week safety and efficacy test of tenapanor for adults with chronic idiopathic constipation

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

Phase 3 Interventional Ardelyx · NCT07382167

This 26-week randomized, double-blind study will test whether taking tenapanor twice daily (5, 25, or 50 mg) helps adults with chronic idiopathic constipation compared with a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment692 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorArdelyx Industry-sponsored
Locations79 sites (Chandler, Arizona and 78 other locations)
Trial IDNCT07382167 on ClinicalTrials.gov

What this trial studies

After a 2-week screening period, eligible adults meeting Rome IV criteria will be randomized to tenapanor 5 mg, 25 mg, 50 mg twice daily, or placebo for 26 weeks in a double-blind, placebo-controlled design with regular safety visits every 2–6 weeks; patients will record daily and weekly symptoms in an electronic diary. The trial includes extensive baseline assessments (medical history, exam, vital signs, ECG, labs) and monitors adverse events throughout treatment. Following the 26-week randomized treatment period there is a 4-week treatment-free safety follow-up with a final safety visit. The primary focus is combined safety and efficacy signals over a longer-term 26-week exposure across multiple doses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 who meet Rome IV criteria for functional constipation, can use an electronic diary daily, and agree to contraception requirements as specified.

Not a fit: Patients with frequent loose or watery stools, recent fecal impaction, or other exclusionary GI conditions (or those unable to comply with daily eDiary reporting) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, tenapanor could increase bowel movement frequency and improve stool consistency and overall constipation symptoms for adults with chronic idiopathic constipation.

How similar studies have performed: Previous tenapanor trials in related constipation disorders, including positive Phase 3 results in IBS-C, support this approach and this study builds on that evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients ≥18 to ≤80 years old at the Screening visit (Visit 1).
2. Meet the Rome IV Diagnostic Criteria for functional constipation.
3. 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.
4. Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization.
5. Meets the entry criteria assessed during the Screening period.
6. Ability to understand and provide input on the assessments in the eDiary.
7. Provide written informed consent before the initiation of any study-specific procedures.
8. Must agree to have daily access to eDiary via a computer, tablet or smart phone

Exclusion Criteria:

1. 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
2. Fecal impaction within 6 months prior to the Screening visit
3. Unexplained and clinically significant alarm symptoms.
4. Functional diarrhea as defined by Rome IV criteria
5. IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria
6. Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit
7. Patient with central nervous system disorder
8. Use of prohibited medications defined by protocol
9. Patient has a history or current evidence of laxative abuse
10. Hepatic dysfunction
11. Positive HIV, hepatitis B or hepatitis C test at screening
12. Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD)
13. Any evidence of or treatment of malignancy within 1 year prior to the Screening visit
14. Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit
15. Pregnant women or women planning to become pregnant during trial participation
16. A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit.
17. Alcohol or substance abuse within 1 year prior to the Screening visit
18. Participation in other clinical trials within 1 month prior to the Screening visit
19. Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial

Where this trial is running

Chandler, Arizona and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Idiopathic ConstipationCIC
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.