Back to Trials
NCT07382167PHASE3Recruiting

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

Ardelyx

Start Date

1/13/2026

Completion Date

6/4/2027

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.

Detailed Description

This study consists of a 2-week Screening period, followed by a 26-week randomized treatment period (RTP), and a 4-week treatment-free Safety Follow-up period. After obtaining study informed consent from patients, the 2-week Screening period starts. Patients will be fully assessed for eligibility into the study. The assessments will include evaluation of inclusion/exclusion criteria, including medical histories, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Patients will also self-report, on information about the status of their constipation symptoms and severity via an electronic diary (eDiary). Patient compliance with the eDiary will be monitored to determine eligibility at the end of screening. Eligible patients will be randomized (Visit 2) to receive tenapanor 5 mg BID (twice a day), 25 mg BID, 50 mg BID, or placebo for 26 consecutive weeks as the double-blind RTP. During this period, patients will continue recording daily assessments of constipation symptoms and weekly assessments of constipation severity in the eDiary. Patients will have return visits every two to six weeks at Weeks 2, 4, 8, 12, 16, 20 and 26(Visit 3-9) to undergo safety assessments. Upon completion of the 26-week RTP, patients will be monitored for AEs (adverse events) during the 4-week treatment-free Safety Follow-up period and complete the Follow-up visit (Visit 10) at the end of this period to undergo safety assessments.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

Tenapanor 5 mg BID

DRUG

Tenapanor 25 mg BID

DRUG

Tenapanor 50 mg BID

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Idiopathic Constipation (CIC)

Locations

G & L Research, LLC

Foley, Alabama 36535

United States

The Center for Clinical Trials

Saraland, Alabama 36571

United States

Arizona Liver Health - Chandler

Chandler, Arizona 85225

United States

Elite Clinical Studies

Phoenix, Arizona 85018

United States

Clinical Research Institute of Arizona, LLC

Sun City West, Arizona 85375

United States

Del Sol Research Management, LLC

Tucson, Arizona 85715

United States

Arkansas Gastroenterology - North Little Rock

North Little Rock, Arkansas 72117

United States

Hope Clinical Research - Canoga Park

Canoga Park, California 91303

United States

GW Research Inc.

Chula Vista, California 91010

United States

Erick H. Alayo Medical Corporation

Chula Vista, California 91910

United States

310 Clinical Research

Inglewood, California 90301

United States

Om Research LLC

Lancaster, California 93534

United States

Clinical Trials Research

Lincoln, California 95648

United States

Acclaim Clinical Research

San Diego, California 92120

United States

San Jose Gastroenterology

San Jose, California 95128

United States

Paragon Rx Clinical, Inc. - Santa Ana

Santa Ana, California 92703

United States

Advanced Research Institute - Denver

Denver, Colorado 80218

United States

Rocky Mountain Gastroenterology (RMG) - Littleton

Lakewood, Colorado 80228

United States

Tekton Research - Longmont, CO

Longmont, Colorado 80501

United States

Proactive Clinical Research

Fort Lauderdale, Florida 33308

United States

Waterway Research

Miami, Florida 33155

United States

Valencia Medical and Research Center

Miami, Florida 33174

United States

IMIC, Inc

Miami, Florida 33176

United States

Harmony Clinical Research, Inc - North Miami Beach

Miami Beach, Florida 33162

United States

Suncoast Clinical Research, Inc. - New Port Richey

New Port Richey, Florida 34652

United States

Sensible Healthcare, LLC

Ocoee, Florida 34761

United States

Harmony Clinical Research - Orlando

Orange City, Florida 32763

United States

Suncoast Clinical Research, Inc. - Palm Harbor

Palm Harbor, Florida 34684

United States

Clinical Research Center of Florida

Pompano Beach, Florida 33060

United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia 30328

United States

DelRicht Clinical Research - Atlanta

Atlanta, Georgia 30329

United States

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia 30060

United States

North Georgia Clinical Research

Woodstock, Georgia 30189

United States

Elite Clinical Trials-Idaho

Blackfoot, Idaho 83221

United States

Treasure Valley Medical Research

Boise, Idaho 83706

United States

GI Alliance - Glenview, IL

Glenview, Illinois 60026

United States

Clinical Investigation Specialists, Inc

Gurnee, Illinois 60031

United States

Southwest Gastroenterology

Oak Lawn, Illinois 60453

United States

Evanston Premier Healthcare Research LLC

Skokie, Illinois 60077

United States

DelRicht Clinical Research - Indianapolis

Indianapolis, Indiana 46202

United States

DelRicht Clinical Research - Overland Park

Overland Park, Kansas 66209

United States

Tekton Research - Wichita, KS

Wichita, Kansas 67218

United States

DelRicht Clinical Research - Louisville

Louisville, Kentucky 40205

United States

Tandem Clinical Research GI - Houma

Houma, Louisiana 70363

United States

DelRicht Clinical Research - Covington

Mandeville, Louisiana 70471

United States

Tandem Clinical Research

Marrero, Louisiana 70072

United States

DelRicht Clinical Research - New Orleans

New Orleans, Louisiana 70115

United States

DelRicht Clinical Research - Prairieville

Prairieville, Louisiana 70769

United States

Delta Research Partners of West Monroe, LLC

West Monroe, Louisiana 71291

United States

Woodholme Gastroenterology

Glen Burnie, Maryland 21061

United States

Elixia SISU BHR - Sprinfield

Springfield, Massachusetts 01103

United States

Bay State Clinical Trials

Watertown, Massachusetts 02472

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

DelRicht Clinical Research - Gulfport

Gulfport, Mississippi 39503

United States

Kansas City Research Institute

Kansas City, Missouri 64131

United States

DelRicht Clinical Research - Springfield

Springfield, Missouri 65807

United States

St. Charles Clinical Research

St Louis, Missouri 63141

United States

DelRicht Clinical Research - Town and Country

Town and Country, Missouri 63017

United States

Gastrointestinal Associates LLP

Columbia Falls, Montana 65201

United States

Jubilee Clinical Research, Inc.

Las Vegas, Nevada 89106

United States

Excel Clinical Research

Las Vegas, Nevada 89109

United States

Digestive Disease Specialists

Las Vegas, Nevada 89128

United States

Advanced Research Institute - Reno

Reno, Nevada 89511

United States

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

Jackson, New Jersey 08724

United States

Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons

Somers Point, New Jersey 08244

United States

Albuquerque Clinical Trials (ACT)

Albuquerque, New Mexico 87102

United States

NY Scientific

Brooklyn, New York 11235

United States

Drug Trials America

Hartsdale, New York 10530

United States

Accellacare of Cary

Cary, North Carolina 27518

United States

Delricht Clinical Research - Badmus

Charlotte, North Carolina 28210

United States

Coastal Research Institute, LLC

Fayetteville, North Carolina 28304

United States

Peters Medical Research

High Point, North Carolina 27260

United States

Lucas Research - Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina 28557

United States

Accellacare of Raleigh

Raleigh, North Carolina 27609

United States

Accellacare of Rocky Mount

Rocky Mount, North Carolina 27804

United States

Accellacare of Salisbury

Salisbury, North Carolina 28144

United States

Accellacare of Piedmont HealthCare

Statesville, North Carolina 28625

United States

Accellacare of Winston-Salem, Triad Neurological Associates

Winston-Salem, North Carolina 27103

United States

Lillestol Research, LLC

Fargo, North Dakota 58104

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio 43213

United States

Remington Davis, Inc.

Columbus, Ohio 43215

United States

Hometown Urgent Care and Research - Huber Heights

Huber Heights, Ohio 45424

United States

Great Lakes Gastroenterology Research

Mentor, Ohio 44060

United States

DelRicht Clinical Research - Tulsa

Tulsa, Oklahoma 74133

United States

Tekton Research - Yukon, OK

Yukon, Oklahoma 73099

United States

Advanced Research Institute - Portland

Tigard, Oregon 97223

United States

DelRicht Clinical Research - Charleston

Charleston, South Carolina 29407

United States

Coastal Carolina Research Center

North Charleston, South Carolina 29405

United States

Accellacare of Bristol

Bristol, Tennessee 37620

United States

DelRicht Clinical Research - Nashville

Hendersonville, Tennessee 37075

United States

New Phase Research & Development - Knoxville

Knoxville, Tennessee 37909

United States

Accellacare of Knoxville

Knoxville, Tennessee 37938

United States

Clinical Neuroscience Solutions, Inc - Memphis

Memphis, Tennessee 38119

United States

Quality Medical Research, PLLC

Nashville, Tennessee 37211

United States

Zenos Clinical Research

Dallas, Texas 75230

United States

EPIC Medical Research

DeSoto, Texas 75115

United States

3A Research

El Paso, Texas 79925

United States

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

North Richland Hills, Texas 76180

United States

LinQ Research, LLC

Pearland, Texas 77584

United States

DelRicht Clinical Research - McKinney

Prosper, Texas 75078

United States

Sun Research Institute

San Antonio, Texas 78215

United States

Texas Gastro Consultants

Tomball, Texas 77375

United States

Advanced Research Institute - Ogden

Ogden, Utah 84405

United States

Wasatch Clinical Research, LLC

Salt Lake City, Utah 84107

United States

Advanced Research Institute - Sandy

Sandy City, Utah 84092

United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia 22911

United States

Health Research of Hampton Roads, Inc. - Newport News

Newport News, Virginia 23606

United States

DelRicht Clinical Research - Vienn

Vienna, Virginia 22182

United States