AzTrials
AzTrials

Chronic Idiopathic Constipation (CIC)Phase 3NCT07382167

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

A Phase 3 study testing Tenapanor 5 mg BID, Tenapanor 25 mg BID and Tenapanor 50 mg BID in people with Chronic Idiopathic Constipation (CIC), run by Ardelyx at 109 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Idiopathic Constipation (CIC)
What is being tested?
Tenapanor 5 mg BID, Tenapanor 25 mg BID and Tenapanor 50 mg BID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
692 participants
Where
109 sitesUnited States
Study dates
13 Jan 2026to 4 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

109 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marica Tambongco contact

(617) 875-7968

mtambongco@ardelyx.com

109 sites in 1 country

United States109 sites, 109 recruiting

  • Albuquerque Clinical Trials (ACT)

    Albuquerque, New Mexico, 87102

    Valerie Escudero, 505-224-7407 ext. 260, vescudero@abqct.com

    Satkirin Khalsa, MD

    Recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Benson Hang, Behang@med.umich.edu

    Borko Nojkov, MD

    Recruiting

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

    Madeline Mendoza, mmendoza@agilecrt.com

    Vasundhara Cheekati, MD

    Recruiting

  • DelRicht Clinical Research - Atlanta

    Atlanta, Georgia, 30329

    Maddie LaQua, 504-336-2667, mlaqua@delricht.com

    Robert Springer, MD

    Recruiting

  • Elite Clinical Trials-Idaho

    Blackfoot, Idaho, 83221

    Berta Bates, 208-643-0006, bbates.ect@gmail.com

    Paul Beckett, MD

    Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

    Rachel Dugdale, rdugdale@tvmedresearch.com

    Neetu Talreja, MD

    Recruiting

  • Accellacare of Bristol

    Bristol, Tennessee, 37620

    Henry Gong, Henry.gong@accellacare.com

    Bernard Grunstra, MD

    Recruiting

  • NY Scientific

    Brooklyn, New York, 11235

    Shahid Mahmood, 347-547-6972, smahmood@nyscientific.net

    Alexander Brun, MD

    Recruiting

  • Hope Clinical Research - Canoga Park

    Canoga Park, California, 91303

    Anitha Roobalingam, aroobalingam@hopeclinical.com

    Hessam Aazami, MD

    Recruiting

  • Accellacare of Cary

    Cary, North Carolina, 27518

    Alexandra Montoya, Alexandra.Montoya@accellacare.com

    Sylvia Shoffner, MD

    Recruiting

  • Arizona Liver Health - Chandler

    Chandler, Arizona, 85225

    Reichard Ruiz, rruiz@azclinicaltrials.com

    Anita Kohli, MD

    Recruiting

  • DelRicht Clinical Research - Charleston

    Charleston, South Carolina, 29407

    Holly Eastridge, heastridge@delricht.com

    E. Marshall Newton, MD

    Recruiting

  • Delricht Clinical Research - Badmus

    Charlotte, North Carolina, 28210

    Keith Logan

    Olabisi Badmus, MD

    Recruiting

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

    Caryn Gibson, 434-825-4554, caryn@cvillemedresearch.com

    Kristen Holtz, MD

    Recruiting

  • GW Research Inc.

    Chula Vista, California, 91010

    Jason Colia, 619-585-8882, jcolia@gwresearch.net

    Patrick H Sweet, MD

    Recruiting

  • Erick H. Alayo Medical Corporation

    Chula Vista, California, 91910

    Marilyn Rodriguez, 619-382-3315, marilyn@gastrosb.com

    Erick Alayo, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Sydney Rubin, rubins4@ccf.org

    Anthony Lembo, MD

    Recruiting

  • Gastrointestinal Associates LLP

    Columbia Falls, Montana, 65201

    Coby Ayers, 573-740-0800, Coby.Ayers@objective.health

    Michael Williams, MD

    Recruiting

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

    Cindy Ma, Cindy.ma@centricityresearch.com

    Sridhar Guduri, MD

    Recruiting

  • Remington Davis, Inc.

    Columbus, Ohio, 43215

    Jordan Tidwell, 614-487-2560, jtidwell@remdavis.com

    Roy St. John, MD

    Recruiting

  • Zenos Clinical Research

    Dallas, Texas, 75230

    Juan Zepeda, jzepeda@allianceclinicalnetwork.com

    Sefanit Gebretsadik, MD

    Recruiting

  • Advanced Research Institute - Denver

    Denver, Colorado, 80218

    Alexandra Mandy, 303-353-2660, alexandra@advresearch.org

    Timothy Dobin, MD

    Recruiting

  • EPIC Medical Research

    DeSoto, Texas, 75115

    Josie Quemado, 425-326-0309, jquemado@epicmedresearch.com

    Haresh Boghara, MD

    Recruiting

  • 3A Research

    El Paso, Texas, 79925

    Angel Ricci, angel@3asites.com

    Aldo Maspons, MD

    Recruiting

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

    Kadie Williams, 218-329-4531, kwilliams@lillestolresearch.com

    Michael Lillestol, MD

    Recruiting

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304

    Brooke Shoffner, 910-500-3146, brooke.shoffner@roviaclinical.com; bshoffner@coastalresearchnc.com

    Arvind Kumar, MD

    Recruiting

  • G & L Research, LLC

    Foley, Alabama, 36535

    Christine Fuller, 251-943-2980, glresearch5@gmail.com

    Nidal Morrar, MD

    Recruiting

  • Proactive Clinical Research

    Fort Lauderdale, Florida, 33308

    Naila Pelegrin, 954-938-2843, npelegrin@proactivecr.com

    David Mishkin, MD

    Recruiting

  • Woodholme Gastroenterology

    Glen Burnie, Maryland, 21061

    Amy Martin, woodholme@jointopo.com

    Kenolisa Onwueme, MD

    Recruiting

  • GI Alliance - Glenview, IL

    Glenview, Illinois, 60026

    Ansharah Asif, ansharah.asif@gialliance.com

    Nina Merel, MD

    Recruiting

  • DelRicht Clinical Research - Gulfport

    Gulfport, Mississippi, 39503

    Amber Laque, 504-336-2667, alaque@delricht.com

    Sean Kerby, MD

    Recruiting

  • Clinical Investigation Specialists, Inc

    Gurnee, Illinois, 60031

    Patrycja Kalwajtys, pkalwajtys@cisresearch.com

    John Agaiby, MD

    Recruiting

  • Drug Trials America

    Hartsdale, New York, 10530

    Jeremy Tark, 914-341-2346, jtark@drugtrialsamerica.com

    Michael Gerdis, MD

    Recruiting

  • DelRicht Clinical Research - Nashville

    Hendersonville, Tennessee, 37075

    Rebecca Hales, 615-234-1655, rhales@delricht.com

    Kymberly Moyer, MD

    Recruiting

  • Peters Medical Research

    High Point, North Carolina, 27260

    Ariyanna Lynch, 336-883-9773, ariyannal@petersmedicalresearch.com

    Roy Peters, MD

    Recruiting

  • Tandem Clinical Research GI - Houma

    Houma, Louisiana, 70363

    Jahel Osornio, 985-219-6501, josornio@tandemclinicalresearch.com

    Conar Fitton, MD

    Recruiting

  • Hometown Urgent Care and Research - Huber Heights

    Huber Heights, Ohio, 45424

    Sheri Price, 937-912-4364, sprice@myhometownuc.com

    Steve Choi, MD

    Recruiting

  • DelRicht Clinical Research - Indianapolis

    Indianapolis, Indiana, 46202

    Hailey Hunziker, 504-336-2667, hhunziker@delricht.com

    Rachael Holliday, MD

    Recruiting

  • 310 Clinical Research

    Inglewood, California, 90301

    Indira Mohabir, 310-878-2636 ext. 1706, imohabir@allianceclinicalnetwork.com

    Soheil Hekmat, MD

    Recruiting

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

    Jackson, New Jersey, 08724

    Joyce Cohen, jcohen@tandemclinicalresearch.com

    William Basri, MD

    Recruiting

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

    Taleah Brown, Taleah.brown@kcri.health

    Paresh Patel, MD

    Recruiting

  • New Phase Research & Development - Knoxville

    Knoxville, Tennessee, 37909

    Avery Oakes, 865-200-8364, aoakes@newphaseresearch.com

    Amanda Miller, MD

    Recruiting

  • Accellacare of Knoxville

    Knoxville, Tennessee, 37938

    Lori Bell, lori.bell@accellacare.com

    Rickey Manning, MD

    Recruiting

  • Rocky Mountain Gastroenterology (RMG) - Littleton

    Lakewood, Colorado, 80228

    Emily Hager, 303-722-8987, rmg@jointopo.com

    Andrew Korson, MD

    Recruiting

  • Om Research LLC

    Lancaster, California, 93534

    Guadalupe Barragan, gbarragan@omclinicaltrials.com

    Jatinder Pruthi, MD

    Recruiting

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106

    Matthew O'Sullivan, 702-631-5000, mosullivan@pinnacleresearch.com

    Elliot Shin, MD

    Recruiting

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

    Stephanie Ruvalcaba, 702-680-1500, sruvalcaba@allianceclinicalnetwork.com

    Robby Ann Quintos, MD

    Recruiting

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

    Vivian Cuevas, 702-790-9114, vcuevas@lvresearch.com

    Michael Zimmerman, MD

    Recruiting

  • Clinical Trials Research

    Lincoln, California, 95648

    Leesa Koskela, 916-434-8230, leesa@ctrsites.com

    Jeffrey D Wayne, MD

    Recruiting

  • Tekton Research - Longmont, CO

    Longmont, Colorado, 80501

    Vanessa Sutton, vanessa.sutton@tektonresearch.com

    Clint Flanagan, MD

    Recruiting

  • DelRicht Clinical Research - Louisville

    Louisville, Kentucky, 40205

    Jessi Walker, jwalker@delricht.com

    Michael Lovelace, MD

    Recruiting

  • DelRicht Clinical Research - Covington

    Mandeville, Louisiana, 70471

    Brittany Bolton, 225-412-0316, bbolton@delricht.com

    Rachael Murphy, MD

    Recruiting

  • Gastrointestinal Specialists of Georgia PC

    Marietta, Georgia, 30060

    Octavia Nichols, 678-819-4237, Onichols@gigeorgia.com

    Aasim Sheikh, MD

    Recruiting

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

    Meg Muli, 504-934-8424 ext. 7048, MMuli@tandemclinicalresearch.com

    Gary Reiss, MD

    Recruiting

  • Clinical Neuroscience Solutions, Inc - Memphis

    Memphis, Tennessee, 38119

    Irene Woods-Powell, 901-843-1045, iwoodspowell@cnshealthcare.com

    Lisa Usdan, MD

    Recruiting

  • Great Lakes Gastroenterology Research

    Mentor, Ohio, 44060

    Christy DeJohn, 440-205-1205 ext. 218, ChristyD@greatlakesgastro.net

    Keith Friedenberg, MD

    Recruiting

  • Waterway Research

    Miami, Florida, 33155

    Claudia Cuellar Ramos, ccramos@waterwayresearch.com

    Guillermo Fonseca, MD

    Recruiting

  • Valencia Medical and Research Center

    Miami, Florida, 33174

    Yamie Chaviano, ychaviano@valenciamedresearch.com

    Inti Fernandez, MD

    Recruiting

  • IMIC, Inc

    Miami, Florida, 33176

    Teresa Valencia, teresa@roviaclinical.com

    Miguel Rodriguez, MD

    Recruiting

  • Harmony Clinical Research, Inc - North Miami Beach

    Miami Beach, Florida, 33162

    Nichole Ramirez, nramirez@hcresearchfl.com

    Adonis Maiquez, MD

    Recruiting

  • Lucas Research - Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

    Crystal Gann, 252-222-5700 ext. 135, Crystal.Gann@centricityresearch.com

    Kathryn Jean Locus, MD

    Recruiting

  • Quality Medical Research, PLLC

    Nashville, Tennessee, 37211

    Christina Stanley, 615-939-5226, cstanley@qualitymedicalresearch.com

    Saras Sharma, MD

    Recruiting

  • DelRicht Clinical Research - New Orleans

    New Orleans, Louisiana, 70115

    Emily Krambeck, 504-336-2667, ekrambeck@delricht.com

    Patrick Dennis, MD

    Recruiting

  • Suncoast Clinical Research, Inc. - New Port Richey

    New Port Richey, Florida, 34652

    Mark Mason, 727-849-4131, mmason@suncoastclinicalresearch.com

    Cathy Barnes, MD

    Recruiting

  • Health Research of Hampton Roads, Inc. - Newport News

    Newport News, Virginia, 23606

    Amanda Fronzaglio, mfronz1@hrhr-inc.com

    George Freeman, MD

    Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

    Emily McCoy, 843-856-3784, Emily.McCoy@coastalcarolinaresearch.com

    Rica Santiago, MD

    Recruiting

  • Arkansas Gastroenterology - North Little Rock

    North Little Rock, Arkansas, 72117

    Courtney Voss, 501-945-9300, courtney@arkgi.net

    Johnathan Goodwin, MD

    Recruiting

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

    North Richland Hills, Texas, 76180

    Ted Melliza, 817-595-3399, t.melliza@nhmr-inc.com

    John Gabriel, MD

    Recruiting

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

    Harish Kumar Gundlapalli, harish.gundlapalli@avicennaclinical.com

    Charles Berkelhammer, MD

    Recruiting

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

    Jenny Kuerth, 407-654-2724, jkuerth@sensiblehealthcare.net

    William (Kelly) Bowman, MD

    Recruiting

  • Advanced Research Institute - Ogden

    Ogden, Utah, 84405

    Nephi Georgi, 801-409-2040, nephi@advresearch.org

    John Lowe, MD

    Recruiting

  • Harmony Clinical Research - Orlando

    Orange City, Florida, 32763

    Jennifer Pages, 305-957-7200, jpages@clinmastery.com

    Glenda Rosa Gonzalez, MD

    Recruiting

  • DelRicht Clinical Research - Overland Park

    Overland Park, Kansas, 66209

    Anthony Alioto, 913-391-7188, aalioto@delricht.com

    Jonathan Jacobs

    Recruiting

  • Suncoast Clinical Research, Inc. - Palm Harbor

    Palm Harbor, Florida, 34684

    Alayna Tiffany, 727-781-3655, atiffany@suncoastclinicalresearch.com

    Gary Goldstein, MD

    Recruiting

  • LinQ Research, LLC

    Pearland, Texas, 77584

    Mustafa Noorbhai, 281-916-4220 ext. 102, mustafa@linqresearchllc.com

    Jignesh Shah, MD

    Recruiting

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

    Evette San Miguel, 602-788-3437, Evette@eliteclinicalstudies.com

    Joseph Lillo, MD

    Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

    Zachary Weiss, zachary@floridacrc.com

    Howard Koch, MD

    Recruiting

  • DelRicht Clinical Research - Prairieville

    Prairieville, Louisiana, 70769

    Brittany Bolton, 225-412-0316, bbolton@delricht.com

    Taylor Sanders, MD

    Recruiting

  • DelRicht Clinical Research - McKinney

    Prosper, Texas, 75078

    Narmin Gilani, 504-336-2667, ngilani@delricht.com

    Jennifer Zomnir, MD

    Recruiting

  • Accellacare of Raleigh

    Raleigh, North Carolina, 27609

    Megan Kopp, 919-783-4895, megan.kopp@accellacare.com

    John Rubino, MD

    Recruiting

  • Advanced Research Institute - Reno

    Reno, Nevada, 89511

    Matt Mehlhaff, 801-409-2040, matt@advresearch.org

    George Vagujhelyi, MD

    Recruiting

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804

    Alexandra Fleming, 252-316-3100, Alexandra.fleming@accellacare.com

    Mark Anderson, MD

    Recruiting

  • Accellacare of Salisbury

    Salisbury, North Carolina, 28144

    Stacy Smith, Stacy.smith@accellacare.com

    Kiran Jagarlamudi, MD

    Recruiting

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

    Annie Hanks, 801-288-0607, ahanks@wasatchcrc.com

    Gene Fuller, MD

    Recruiting

  • Sun Research Institute

    San Antonio, Texas, 78215

    Melissa Mageno, 210-227-1289, mmageno@sunresearch.com

    Leonel Reyes, MD

    Recruiting

  • Acclaim Clinical Research

    San Diego, California, 92120

    Sandra Nissa, snissan@allianceclinicalnetwork.com

    Julie Vu, MD

    Recruiting

  • San Jose Gastroenterology

    San Jose, California, 95128

    Charitha Ratakonda, cratakonda@jointopo.com

    Geeta Kutty, MD

    Recruiting

  • Advanced Research Institute - Sandy

    Sandy City, Utah, 84092

    Faith Sanborn, 801-409-2040, faith@advresearch.org

    Robert Barnett, MD

    Recruiting

  • Paragon Rx Clinical, Inc. - Santa Ana

    Santa Ana, California, 92703

    Thy Tran, Thy.Tran@prxclinical.com

    Long Dang, MD

    Recruiting

  • The Center for Clinical Trials

    Saraland, Alabama, 36571

    JoAnn Ladner, 228-388-3112, Joanne@thecenterforclinicaltrials.com

    Howard Rubenstein, MD

    Recruiting

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077

    Galina Tsirulnik, galina@evanstonpremier.com

    Jeffrey Geohas, MD

    Recruiting

  • Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons

    Somers Point, New Jersey, 08244

    Ashley Sanchez, 609-715-1244, ASanchez@tandemclinicalresearch.com

    Paul Ljubich, MD

    Recruiting

  • Elixia SISU BHR - Sprinfield

    Springfield, Massachusetts, 01103

    Hannah Sheets, 413-305-1144, hannah.sheets@elixiahealth.com

    Brittany Perreault, MD

    Recruiting

  • DelRicht Clinical Research - Springfield

    Springfield, Missouri, 65807

    Austin Christian, 504-336-2667, achristian@delricht.com

    Luke Van Kirk, MD

    Recruiting

  • St. Charles Clinical Research

    St Louis, Missouri, 63141

    Kelly Moushey, 636-477-6366, k.moushey@stcharlesclinicalresearch.com

    Leonard Weinstock, MD

    Recruiting

  • Accellacare of Piedmont HealthCare

    Statesville, North Carolina, 28625

    Amelia Evans, Amelia.Evans@accellacare.com

    Dwight Bellingham, MD

    Recruiting

  • Clinical Research Institute of Arizona, LLC

    Sun City West, Arizona, 85375

    Jamie Foreman, 623-223-1580, jforeman@criofaz.com

    Jalal Abbas, MD

    Recruiting

  • Advanced Research Institute - Portland

    Tigard, Oregon, 97223

    Jessica Weed, 503-610-0033, jessicaw@advresearch.org

    James Bergthold, MD

    Recruiting

  • Texas Gastro Consultants

    Tomball, Texas, 77375

    Lucia Sabido, 281-841-5798, lsabido@horizoncrg.com

    Amar Dodda, MD

    Recruiting

  • DelRicht Clinical Research - Town and Country

    Town and Country, Missouri, 63017

    Nicole Huddleston, 504-336-2667, nhuddleston@delricht.com

    Amy Roberts, MD

    Recruiting

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

    Maria Gallegos, 520-481-8464, mgallegos@delsolresearch.com

    Bassel Kisso, MD

    Recruiting

  • DelRicht Clinical Research - Tulsa

    Tulsa, Oklahoma, 74133

    Ashley Smith, 918-932-2276, asmith@delricht.com

    Melita Tate, MD

    Recruiting

  • DelRicht Clinical Research - Vienn

    Vienna, Virginia, 22182

    Andy Garmon, 504-336-2667, agarmon@delricht.com

    Vijayendra Jaligam, MD

    Recruiting

  • Bay State Clinical Trials

    Watertown, Massachusetts, 02472

    Tina LaFleur, 617-923-0328, tmlbsct@gmail.com

    Henry David Mitcheson, MD

    Recruiting

  • Delta Research Partners of West Monroe, LLC

    West Monroe, Louisiana, 71291

    Jennifer Davidson, 318-538-0085, jennifer.davidson@roviaclinical.com

    Clarence Dunn, MD

    Recruiting

  • Tekton Research - Wichita, KS

    Wichita, Kansas, 67218

    Brooke Carr, brooke.carr@tektonresearch.com

    Brandon Alleman, MD

    Recruiting

  • Accellacare of Winston-Salem, Triad Neurological Associates

    Winston-Salem, North Carolina, 27103

    Paris Bennett, Paris.Bennett@Accellacare.com

    Robert Holmes, MD

    Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

    Shelby Satterwhite, shelby.satterwhite@ngclinicalresearch.com

    Bram Wieskopf, MD

    Recruiting

  • Tekton Research - Yukon, OK

    Yukon, Oklahoma, 73099

    Shawna Hennigh, 405-594-7712, shawna.hennigh@tektonresearch.com

    Robert Lockwood, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Tenapanor 5 mg BID, Tenapanor 25 mg BID, Tenapanor 50 mg BID, Placebo
Keywords
CIC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenapanor 5 mg BIDDrug

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

  • Tenapanor 25 mg BIDDrug

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

  • Tenapanor 50 mg BIDDrug

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

  • PlaceboDrug

    Patients will receive matching placebo BID

Study groups in NCT07382167
Study groupRoleWhat they receive
Tenapanor 5 mg BIDExperimentalPatients will be randomized to receive 5 mg tenapanor twice daily.
Receives: Drug: Tenapanor 5 mg BID
Tenapanor 25 mg BIDExperimentalPatients will be randomized to receive 25 mg tenapanor twice daily.
Receives: Drug: Tenapanor 25 mg BID
Tenapanor 50 mg BIDExperimentalPatients will be randomized to receive 50 mg tenapanor twice daily.
Receives: Drug: Tenapanor 50 mg BID
Placebo ComparatorPlacebo comparatorPatients will be randomized to receive matching placebo twice daily.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Durable complete spontaneous bowel movements (CSBM) response

    Durable complete spontaneous bowel movements (CSBM) response is defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period and and for ≥3 of the last 4 weeks of the first 12 weeks of randomized treatment period

    Measured: 12 Weeks

Secondary outcomes (5)

  1. 9/12 week complete spontaneous bowel movements (CSBM) response

    9/12 week complete spontaneous bowel movements (CSBM) response defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period.

    Measured: 12 Weeks

  2. Change from baseline in complete spontaneous bowel movements (CSBM) frequency

    Change from baseline over the first 12 weeks of the randomized treatment period in complete spontaneous bowel movements (CSBM) frequency

    Measured: 12 Weeks

  3. Change from baseline in spontaneous bowel movement (SBM) frequency

    Change from baseline over the first 12 weeks of the randomized treatment period in spontaneous bowel movement (SBM) frequency

    Measured: 12 Weeks

  4. Change from baseline in stool consistency

    Change from baseline over the first 12 weeks of the randomized treatment period in stool consistency

    Measured: 12 Weeks

  5. Change from baseline in stool straining

    Change from baseline over the first 12 weeks of the randomized treatment period in straining

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start13 Jan 2026
  3. Primary completion26 Feb 2027 (estimated)
  4. Study completion4 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
692 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07382167
Sponsor's protocol ID
TEN-03-301
Status last verified
Jun 2026
First submitted
26 Jan 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenapanor 5 mg BID, Tenapanor 25 mg BID and Tenapanor 50 mg BID in people with Chronic Idiopathic Constipation (CIC), run by Ardelyx at 109 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marica Tambongco ((617) 875-7968, mtambongco@ardelyx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable complete spontaneous bowel movements (CSBM) response (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07382167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in