Recruiting
Phase 3

Tenapanor

Sponsor:

Ardelyx

Code:

NCT07382167

Conditions

Chronic Idiopathic Constipation (CIC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tenapanor 5 mg BID

Tenapanor 25 mg BID

Tenapanor 50 mg BID

Placebo

Study Details

Brief 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.

Conditions

Chronic Idiopathic Constipation (CIC)

Study ID

NCT07382167

Start date

Jan 13, 2026

Status verified date

Jun, 2026

Completion date

Jun 4, 2027

Anticipated

Primary completion date

Feb 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

692 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tenapanor 5 mg BID

Patients will be randomized to receive 5 mg tenapanor twice daily.

experimental: Tenapanor 25 mg BID

Patients will be randomized to receive 25 mg tenapanor twice daily.

experimental: Tenapanor 50 mg BID

Patients will be randomized to receive 50 mg tenapanor twice daily.

placebo comparator: Placebo Comparator

Patients will be randomized to receive matching placebo twice daily.

Interventions

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

Primary outcome measure

  • Durable complete spontaneous bowel movements (CSBM) response [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Locations

G & L Research, LLC

Recruiting

Foley, Alabama, United States, 36535

Contacts

Principal Investigator:

Nidal Morrar, MD

The Center for Clinical Trials

Recruiting

Saraland, Alabama, United States, 36571

Contacts

Principal Investigator:

Howard Rubenstein, MD

Arizona Liver Health - Chandler

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Principal Investigator:

Anita Kohli, MD

Elite Clinical Studies

Recruiting

Phoenix, Arizona, United States, 85018

Contacts

Principal Investigator:

Joseph Lillo, MD

Clinical Research Institute of Arizona, LLC

Recruiting

Sun City West, Arizona, United States, 85375

Contacts

Principal Investigator:

Jalal Abbas, MD

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Principal Investigator:

Bassel Kisso, MD

Arkansas Gastroenterology - North Little Rock

Recruiting

North Little Rock, Arkansas, United States, 72117

Contacts

Principal Investigator:

Johnathan Goodwin, MD

Hope Clinical Research - Canoga Park

Recruiting

Canoga Park, California, United States, 91303

Contacts

Principal Investigator:

Hessam Aazami, MD

GW Research Inc.

Recruiting

Chula Vista, California, United States, 91010

Contacts

Principal Investigator:

Patrick H Sweet, MD

Erick H. Alayo Medical Corporation

Recruiting

Chula Vista, California, United States, 91910

Contacts

Principal Investigator:

Erick Alayo, MD

310 Clinical Research

Recruiting

Inglewood, California, United States, 90301

Contacts

Principal Investigator:

Soheil Hekmat, MD

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

Contacts

Principal Investigator:

Jatinder Pruthi, MD

Clinical Trials Research

Recruiting

Lincoln, California, United States, 95648

Contacts

Principal Investigator:

Jeffrey D Wayne, MD

Acclaim Clinical Research

Recruiting

San Diego, California, United States, 92120

Contacts

Principal Investigator:

Julie Vu, MD

San Jose Gastroenterology

Recruiting

San Jose, California, United States, 95128

Contacts

Charitha Ratakonda

cratakonda@jointopo.com

Principal Investigator:

Geeta Kutty, MD

Paragon Rx Clinical, Inc. - Santa Ana

Recruiting

Santa Ana, California, United States, 92703

Contacts

Principal Investigator:

Long Dang, MD

Advanced Research Institute - Denver

Recruiting

Denver, Colorado, United States, 80218

Contacts

Principal Investigator:

Timothy Dobin, MD

Rocky Mountain Gastroenterology (RMG) - Littleton

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

Principal Investigator:

Andrew Korson, MD

Tekton Research - Longmont, CO

Recruiting

Longmont, Colorado, United States, 80501

Contacts

Principal Investigator:

Clint Flanagan, MD

Proactive Clinical Research

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Principal Investigator:

David Mishkin, MD

Waterway Research

Recruiting

Miami, Florida, United States, 33155

Contacts

Claudia Cuellar Ramos

ccramos@waterwayresearch.com

Principal Investigator:

Guillermo Fonseca, MD

Valencia Medical and Research Center

Recruiting

Miami, Florida, United States, 33174

Contacts

Principal Investigator:

Inti Fernandez, MD

IMIC, Inc

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Miguel Rodriguez, MD

Harmony Clinical Research, Inc - North Miami Beach

Recruiting

Miami Beach, Florida, United States, 33162

Contacts

Principal Investigator:

Adonis Maiquez, MD

Suncoast Clinical Research, Inc. - New Port Richey

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

Principal Investigator:

Cathy Barnes, MD

Sensible Healthcare, LLC

Recruiting

Ocoee, Florida, United States, 34761

Contacts

Principal Investigator:

William (Kelly) Bowman, MD

Harmony Clinical Research - Orlando

Recruiting

Orange City, Florida, United States, 32763

Contacts

Principal Investigator:

Glenda Rosa Gonzalez, MD

Suncoast Clinical Research, Inc. - Palm Harbor

Recruiting

Palm Harbor, Florida, United States, 34684

Contacts

Principal Investigator:

Gary Goldstein, MD

Clinical Research Center of Florida

Recruiting

Pompano Beach, Florida, United States, 33060

Contacts

Principal Investigator:

Howard Koch, MD

Agile Clinical Research Trials, LLC

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Madeline Mendoza

mmendoza@agilecrt.com

Principal Investigator:

Vasundhara Cheekati, MD

DelRicht Clinical Research - Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Principal Investigator:

Robert Springer, MD

Gastrointestinal Specialists of Georgia PC

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Principal Investigator:

Aasim Sheikh, MD

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

Principal Investigator:

Bram Wieskopf, MD

Elite Clinical Trials-Idaho

Recruiting

Blackfoot, Idaho, United States, 83221

Contacts

Principal Investigator:

Paul Beckett, MD

Treasure Valley Medical Research

Recruiting

Boise, Idaho, United States, 83706

Contacts

Principal Investigator:

Neetu Talreja, MD

GI Alliance - Glenview, IL

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Principal Investigator:

Nina Merel, MD

Clinical Investigation Specialists, Inc

Recruiting

Gurnee, Illinois, United States, 60031

Contacts

Patrycja Kalwajtys

pkalwajtys@cisresearch.com

Principal Investigator:

John Agaiby, MD

Southwest Gastroenterology

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Principal Investigator:

Charles Berkelhammer, MD

Evanston Premier Healthcare Research LLC

Recruiting

Skokie, Illinois, United States, 60077

Contacts

Principal Investigator:

Jeffrey Geohas, MD

DelRicht Clinical Research - Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Rachael Holliday, MD

DelRicht Clinical Research - Overland Park

Recruiting

Overland Park, Kansas, United States, 66209

Contacts

Principal Investigator:

Jonathan Jacobs

Tekton Research - Wichita, KS

Recruiting

Wichita, Kansas, United States, 67218

Contacts

Principal Investigator:

Brandon Alleman, MD

DelRicht Clinical Research - Louisville

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Principal Investigator:

Michael Lovelace, MD

Tandem Clinical Research GI - Houma

Recruiting

Houma, Louisiana, United States, 70363

Contacts

Principal Investigator:

Conar Fitton, MD

DelRicht Clinical Research - Covington

Recruiting

Mandeville, Louisiana, United States, 70471

Contacts

Principal Investigator:

Rachael Murphy, MD

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Principal Investigator:

Gary Reiss, MD

DelRicht Clinical Research - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Principal Investigator:

Patrick Dennis, MD

DelRicht Clinical Research - Prairieville

Recruiting

Prairieville, Louisiana, United States, 70769

Contacts

Principal Investigator:

Taylor Sanders, MD

Delta Research Partners of West Monroe, LLC

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Principal Investigator:

Clarence Dunn, MD

Woodholme Gastroenterology

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Principal Investigator:

Kenolisa Onwueme, MD

Elixia SISU BHR - Sprinfield

Recruiting

Springfield, Massachusetts, United States, 01103

Contacts

Principal Investigator:

Brittany Perreault, MD

Bay State Clinical Trials

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Principal Investigator:

Henry David Mitcheson, MD

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Borko Nojkov, MD

DelRicht Clinical Research - Gulfport

Recruiting

Gulfport, Mississippi, United States, 39503

Contacts

Principal Investigator:

Sean Kerby, MD

Kansas City Research Institute

Recruiting

Kansas City, Missouri, United States, 64131

Contacts

Principal Investigator:

Paresh Patel, MD

DelRicht Clinical Research - Springfield

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Principal Investigator:

Luke Van Kirk, MD

St. Charles Clinical Research

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Principal Investigator:

Leonard Weinstock, MD

DelRicht Clinical Research - Town and Country

Recruiting

Town and Country, Missouri, United States, 63017

Contacts

Principal Investigator:

Amy Roberts, MD

Gastrointestinal Associates LLP

Recruiting

Columbia Falls, Montana, United States, 65201

Contacts

Principal Investigator:

Michael Williams, MD

Jubilee Clinical Research, Inc.

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Principal Investigator:

Elliot Shin, MD

Excel Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Principal Investigator:

Robby Ann Quintos, MD

Digestive Disease Specialists

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Principal Investigator:

Michael Zimmerman, MD

Advanced Research Institute - Reno

Recruiting

Reno, Nevada, United States, 89511

Contacts

Principal Investigator:

George Vagujhelyi, MD

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

Recruiting

Jackson, New Jersey, United States, 08724

Contacts

Principal Investigator:

William Basri, MD

Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons

Recruiting

Somers Point, New Jersey, United States, 08244

Contacts

Principal Investigator:

Paul Ljubich, MD

Albuquerque Clinical Trials (ACT)

Recruiting

Albuquerque, New Mexico, United States, 87102

Contacts

Principal Investigator:

Satkirin Khalsa, MD

NY Scientific

Recruiting

Brooklyn, New York, United States, 11235

Contacts

Principal Investigator:

Alexander Brun, MD

Drug Trials America

Recruiting

Hartsdale, New York, United States, 10530

Contacts

Principal Investigator:

Michael Gerdis, MD

Accellacare of Cary

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Principal Investigator:

Sylvia Shoffner, MD

Delricht Clinical Research - Badmus

Recruiting

Charlotte, North Carolina, United States, 28210

Principal Investigator:

Olabisi Badmus, MD

Coastal Research Institute, LLC

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Principal Investigator:

Arvind Kumar, MD

Peters Medical Research

Recruiting

High Point, North Carolina, United States, 27260

Contacts

Principal Investigator:

Roy Peters, MD

Lucas Research - Diabetes & Endocrinology Consultants, PC

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Principal Investigator:

Kathryn Jean Locus, MD

Accellacare of Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Contacts

Principal Investigator:

John Rubino, MD

Accellacare of Rocky Mount

Recruiting

Rocky Mount, North Carolina, United States, 27804

Contacts

Principal Investigator:

Mark Anderson, MD

Accellacare of Salisbury

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Principal Investigator:

Kiran Jagarlamudi, MD

Accellacare of Piedmont HealthCare

Recruiting

Statesville, North Carolina, United States, 28625

Contacts

Principal Investigator:

Dwight Bellingham, MD

Accellacare of Winston-Salem, Triad Neurological Associates

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Principal Investigator:

Robert Holmes, MD

Lillestol Research, LLC

Recruiting

Fargo, North Dakota, United States, 58104

Contacts

Principal Investigator:

Michael Lillestol, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Sydney Rubin

rubins4@ccf.org

Principal Investigator:

Anthony Lembo, MD

Centricity Research Columbus Ohio Multispecialty

Recruiting

Columbus, Ohio, United States, 43213

Contacts

Principal Investigator:

Sridhar Guduri, MD

Remington Davis, Inc.

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Principal Investigator:

Roy St. John, MD

Hometown Urgent Care and Research - Huber Heights

Recruiting

Huber Heights, Ohio, United States, 45424

Contacts

Principal Investigator:

Steve Choi, MD

Great Lakes Gastroenterology Research

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Principal Investigator:

Keith Friedenberg, MD

DelRicht Clinical Research - Tulsa

Recruiting

Tulsa, Oklahoma, United States, 74133

Contacts

Principal Investigator:

Melita Tate, MD

Tekton Research - Yukon, OK

Recruiting

Yukon, Oklahoma, United States, 73099

Contacts

Principal Investigator:

Robert Lockwood, MD

Advanced Research Institute - Portland

Recruiting

Tigard, Oregon, United States, 97223

Contacts

Principal Investigator:

James Bergthold, MD

DelRicht Clinical Research - Charleston

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Principal Investigator:

E. Marshall Newton, MD

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

Contacts

Principal Investigator:

Rica Santiago, MD

Accellacare of Bristol

Recruiting

Bristol, Tennessee, United States, 37620

Contacts

Principal Investigator:

Bernard Grunstra, MD

DelRicht Clinical Research - Nashville

Recruiting

Hendersonville, Tennessee, United States, 37075

Contacts

Principal Investigator:

Kymberly Moyer, MD

New Phase Research & Development - Knoxville

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Principal Investigator:

Amanda Miller, MD

Accellacare of Knoxville

Recruiting

Knoxville, Tennessee, United States, 37938

Contacts

Principal Investigator:

Rickey Manning, MD

Clinical Neuroscience Solutions, Inc - Memphis

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Principal Investigator:

Lisa Usdan, MD

Quality Medical Research, PLLC

Recruiting

Nashville, Tennessee, United States, 37211

Contacts

Principal Investigator:

Saras Sharma, MD

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Contacts

Principal Investigator:

Sefanit Gebretsadik, MD

EPIC Medical Research

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Principal Investigator:

Haresh Boghara, MD

3A Research

Recruiting

El Paso, Texas, United States, 79925

Contacts

Principal Investigator:

Aldo Maspons, MD

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

Recruiting

North Richland Hills, Texas, United States, 76180

Contacts

Principal Investigator:

John Gabriel, MD

LinQ Research, LLC

Recruiting

Pearland, Texas, United States, 77584

Contacts

Principal Investigator:

Jignesh Shah, MD

DelRicht Clinical Research - McKinney

Recruiting

Prosper, Texas, United States, 75078

Contacts

Principal Investigator:

Jennifer Zomnir, MD

Sun Research Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Principal Investigator:

Leonel Reyes, MD

Texas Gastro Consultants

Recruiting

Tomball, Texas, United States, 77375

Contacts

Principal Investigator:

Amar Dodda, MD

Advanced Research Institute - Ogden

Recruiting

Ogden, Utah, United States, 84405

Contacts

Principal Investigator:

John Lowe, MD

Wasatch Clinical Research, LLC

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

Principal Investigator:

Gene Fuller, MD

Advanced Research Institute - Sandy

Recruiting

Sandy City, Utah, United States, 84092

Contacts

Principal Investigator:

Robert Barnett, MD

Charlottesville Medical Research Center, LLC

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

Principal Investigator:

Kristen Holtz, MD

Health Research of Hampton Roads, Inc. - Newport News

Recruiting

Newport News, Virginia, United States, 23606

Contacts

Amanda Fronzaglio

mfronz1@hrhr-inc.com

Principal Investigator:

George Freeman, MD

DelRicht Clinical Research - Vienn

Recruiting

Vienna, Virginia, United States, 22182

Contacts

Principal Investigator:

Vijayendra Jaligam, MD

More Information

Sponsor

Ardelyx

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • CIC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ardelyx on 2026-06-04.