A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation (CIC)

In brief

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.

Key facts

Study ID

NCT07382167

Run by

Ardelyx

People needed

692

Starts

2026-01-13

Expected to finish

2027-06-04

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Center for Clinical Trials — Saraland, Alabama, United States (enrolling)
• Arizona Liver Health - Chandler — Chandler, Arizona, United States (enrolling)
• Elite Clinical Studies — Phoenix, Arizona, United States (enrolling)
• Clinical Research Institute of Arizona, LLC — Sun City West, Arizona, United States (enrolling)
• Del Sol Research Management, LLC — Tucson, Arizona, United States (enrolling)
• Arkansas Gastroenterology - North Little Rock — North Little Rock, Arkansas, United States (enrolling)
• Hope Clinical Research - Canoga Park — Canoga Park, California, United States (enrolling)
• GW Research Inc. — Chula Vista, California, United States (enrolling)
• Erick H. Alayo Medical Corporation — Chula Vista, California, United States (enrolling)
• 310 Clinical Research — Inglewood, California, United States (enrolling)
• Om Research LLC — Lancaster, California, United States (enrolling)
• Clinical Trials Research — Lincoln, California, United States (enrolling)
• Acclaim Clinical Research — San Diego, California, United States (enrolling)
• San Jose Gastroenterology — San Jose, California, United States (enrolling)
• Paragon Rx Clinical, Inc. - Santa Ana — Santa Ana, California, United States (enrolling)
• Advanced Research Institute - Denver — Denver, Colorado, United States (enrolling)
• Rocky Mountain Gastroenterology (RMG) - Littleton — Lakewood, Colorado, United States (enrolling)
• Tekton Research - Longmont, CO — Longmont, Colorado, United States (enrolling)
• Proactive Clinical Research — Fort Lauderdale, Florida, United States (enrolling)
• Waterway Research — Miami, Florida, United States (enrolling)
• Valencia Medical and Research Center — Miami, Florida, United States (enrolling)
• IMIC, Inc — Miami, Florida, United States (enrolling)
• Harmony Clinical Research, Inc - North Miami Beach — Miami Beach, Florida, United States (enrolling)
• Suncoast Clinical Research, Inc. - New Port Richey — New Port Richey, Florida, United States (enrolling)
• G & L Research, LLC — Foley, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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