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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• G & L Research, LLC
  Foley, Alabama, United States Recruiting
• The Center for Clinical Trials
  Saraland, Alabama, United States Recruiting
• Arizona Liver Health - Chandler
  Chandler, Arizona, United States Recruiting
• Elite Clinical Studies
  Phoenix, Arizona, United States Recruiting
• Clinical Research Institute of Arizona, LLC
  Sun City West, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting

+59 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Marica Tambongco
• Email: mtambongco@ardelyx.com
• Phone: (617) 875-7968

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.