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RECRUITING

NCT07382167

PHASE3

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

Sponsor: Ardelyx

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

692

Start Date

2026-01-13

Completion Date

2027-06-04

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Chronic Idiopathic Constipation (CIC)

Interventions

DRUG

Tenapanor 5 mg BID

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

DRUG

Tenapanor 25 mg BID

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

DRUG

Tenapanor 50 mg BID

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

DRUG

Placebo

Patients will receive matching placebo BID

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

Locations (79)

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Chandler, Arizona, United States

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Arkansas Gastroenterology - North Little Rock

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GW Research Inc.

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Erick H. Alayo Medical Corporation

Chula Vista, California, United States

310 Clinical Research

Inglewood, California, United States

Om Research LLC

Lancaster, California, United States

Clinical Trials Research

Lincoln, California, United States

Paragon Rx Clinical, Inc. - Santa Ana

Santa Ana, California, United States

Rocky Mountain Gastroenterology (RMG) - Littleton

Lakewood, Colorado, United States

Proactive Clinical Research

Fort Lauderdale, Florida, United States

Valencia Medical and Research Center

Miami, Florida, United States

IMIC, Inc

Miami, Florida, United States

Suncoast Clinical Research, Inc. - New Port Richey

New Port Richey, Florida, United States

Sensible Healthcare, LLC

Ocoee, Florida, United States

Harmony Clinical Research - Orlando

Orange City, Florida, United States

Suncoast Clinical Research, Inc. - Palm Harbor

Palm Harbor, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

DelRicht Clinical Research - Atlanta

Atlanta, Georgia, United States

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Elite Clinical Trials-Idaho

Blackfoot, Idaho, United States

Clinical Investigation Specialists, Inc

Gurnee, Illinois, United States

DelRicht Clinical Research - Indianapolis

Indianapolis, Indiana, United States

DelRicht Clinical Research - Overland Park

Overland Park, Kansas, United States

DelRicht Clinical Research - Louisville

Louisville, Kentucky, United States

Tandem Clinical Research GI - Houma

Houma, Louisiana, United States

DelRicht Clinical Research - Covington

Mandeville, Louisiana, United States

Tandem Clinical Research

Marrero, Louisiana, United States

DelRicht Clinical Research - New Orleans

New Orleans, Louisiana, United States

DelRicht Clinical Research - Prairieville

Prairieville, Louisiana, United States

Delta Research Partners of West Monroe, LLC

West Monroe, Louisiana, United States

Woodholme Gastroenterology

Glen Burnie, Maryland, United States

Elixia SISU BHR - Sprinfield

Springfield, Massachusetts, United States

Bay State Clinical Trials

Watertown, Massachusetts, United States

DelRicht Clinical Research - Gulfport

Gulfport, Mississippi, United States

Kansas City Research Institute

Kansas City, Missouri, United States

DelRicht Clinical Research - Springfield

Springfield, Missouri, United States

St. Charles Clinical Research

St Louis, Missouri, United States

DelRicht Clinical Research - Town and Country

Town and Country, Missouri, United States

Gastrointestinal Associates LLP

Columbia Falls, Montana, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Digestive Disease Specialists

Las Vegas, Nevada, United States

Advanced Research Institute - Reno

Reno, Nevada, United States

Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson

Jackson, New Jersey, United States

Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons

Somers Point, New Jersey, United States

Albuquerque Clinical Trials (ACT)

Albuquerque, New Mexico, United States

NY Scientific

Brooklyn, New York, United States

Drug Trials America

Hartsdale, New York, United States

Delricht Clinical Research - Badmus

Charlotte, North Carolina, United States

Peters Medical Research

High Point, North Carolina, United States

Lucas Research - Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, United States

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Remington Davis, Inc.

Columbus, Ohio, United States

Hometown Urgent Care and Research - Huber Heights

Huber Heights, Ohio, United States

Great Lakes Gastroenterology Research

Mentor, Ohio, United States

DelRicht Clinical Research - Tulsa

Tulsa, Oklahoma, United States

Tekton Research - Yukon, OK

Yukon, Oklahoma, United States

Advanced Research Institute - Portland

Tigard, Oregon, United States

DelRicht Clinical Research - Charleston

Charleston, South Carolina, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Accellacare of Bristol

Bristol, Tennessee, United States

DelRicht Clinical Research - Nashville

Hendersonville, Tennessee, United States

New Phase Research & Development - Knoxville

Knoxville, Tennessee, United States

Quality Medical Research, PLLC

Nashville, Tennessee, United States

Zenos Clinical Research

Dallas, Texas, United States

EPIC Medical Research

DeSoto, Texas, United States

3A Research

El Paso, Texas, United States

North Hills Medical Research Inc. (North Hills Family Medicine)

North Richland Hills, Texas, United States

LinQ Research, LLC

Pearland, Texas, United States

DelRicht Clinical Research - McKinney

Prosper, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Advanced Research Institute - Ogden

Ogden, Utah, United States

Advanced Research Institute - Sandy

Sandy City, Utah, United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, United States

Health Research of Hampton Roads, Inc. - Newport News

Newport News, Virginia, United States

DelRicht Clinical Research - Vienn

Vienna, Virginia, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (79)