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Clinical Trials in the USA / NCT07382167
Recruiting Phase 3

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

NCT07382167 · tracked via the Priya Life Science USA tracker
Sponsor
Ardelyx
Phase
Phase 3
Started
2026-01-13
Last updated
2026-06-04

Condition(s) studied

Chronic Idiopathic Constipation (CIC)

Investigational drug(s) / intervention(s)

Tenapanor 5 mg BIDTenapanor 25 mg BIDTenapanor 50 mg BIDPlacebo

Tenapanor 5 mg BID: Patients will receive tenapanor 5 mg BID (total of 10 mg daily)

Tenapanor 25 mg BID: Patients will receive tenapanor 25 mg BID (total of 50 mg daily)

Tenapanor 50 mg BID: Patients will receive tenapanor 50 mg BID (total of 100 mg daily)

Placebo: Patients will receive matching placebo BID

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (109)

FacilityCityRegionStatus
G & L Research, LLC Foley Alabama Recruiting
The Center for Clinical Trials Saraland Alabama Recruiting
Arizona Liver Health - Chandler Chandler Arizona Recruiting
Elite Clinical Studies Phoenix Arizona Recruiting
Clinical Research Institute of Arizona, LLC Sun City West Arizona Recruiting
Del Sol Research Management, LLC Tucson Arizona Recruiting
Arkansas Gastroenterology - North Little Rock North Little Rock Arkansas Recruiting
Hope Clinical Research - Canoga Park Canoga Park California Recruiting
GW Research Inc. Chula Vista California Recruiting
Erick H. Alayo Medical Corporation Chula Vista California Recruiting
310 Clinical Research Inglewood California Recruiting
Om Research LLC Lancaster California Recruiting
Clinical Trials Research Lincoln California Recruiting
Acclaim Clinical Research San Diego California Recruiting
San Jose Gastroenterology San Jose California Recruiting
Paragon Rx Clinical, Inc. - Santa Ana Santa Ana California Recruiting
Advanced Research Institute - Denver Denver Colorado Recruiting
Rocky Mountain Gastroenterology (RMG) - Littleton Lakewood Colorado Recruiting
Tekton Research - Longmont, CO Longmont Colorado Recruiting
Proactive Clinical Research Fort Lauderdale Florida Recruiting
Waterway Research Miami Florida Recruiting
Valencia Medical and Research Center Miami Florida Recruiting
IMIC, Inc Miami Florida Recruiting
Harmony Clinical Research, Inc - North Miami Beach Miami Beach Florida Recruiting
Suncoast Clinical Research, Inc. - New Port Richey New Port Richey Florida Recruiting
Sensible Healthcare, LLC Ocoee Florida Recruiting
Harmony Clinical Research - Orlando Orange City Florida Recruiting
Suncoast Clinical Research, Inc. - Palm Harbor Palm Harbor Florida Recruiting
Clinical Research Center of Florida Pompano Beach Florida Recruiting
Agile Clinical Research Trials, LLC Atlanta Georgia Recruiting
DelRicht Clinical Research - Atlanta Atlanta Georgia Recruiting
Gastrointestinal Specialists of Georgia PC Marietta Georgia Recruiting
North Georgia Clinical Research Woodstock Georgia Recruiting
Elite Clinical Trials-Idaho Blackfoot Idaho Recruiting
Treasure Valley Medical Research Boise Idaho Recruiting
GI Alliance - Glenview, IL Glenview Illinois Recruiting
Clinical Investigation Specialists, Inc Gurnee Illinois Recruiting
Southwest Gastroenterology Oak Lawn Illinois Recruiting
Evanston Premier Healthcare Research LLC Skokie Illinois Recruiting
DelRicht Clinical Research - Indianapolis Indianapolis Indiana Recruiting

+ 69 more sites — see the full list on the official registry below.

More Ardelyx trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07382167 on ClinicalTrials.gov ↗ ← All trials in the USA