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A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Sponsor: Ardelyx
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
2026-06-04
Healthy Volunteers
No
Conditions
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
Locations (109)
G & L Research, LLC
Foley, Alabama, United States
The Center for Clinical Trials
Saraland, Alabama, United States
Arizona Liver Health - Chandler
Chandler, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, United States
Hope Clinical Research - Canoga Park
Canoga Park, California, United States
GW Research Inc.
Chula Vista, California, United States
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
Acclaim Clinical Research
San Diego, California, United States
San Jose Gastroenterology
San Jose, California, United States
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, United States
Advanced Research Institute - Denver
Denver, Colorado, United States
Rocky Mountain Gastroenterology (RMG) - Littleton
Lakewood, Colorado, United States
Tekton Research - Longmont, CO
Longmont, Colorado, United States
Proactive Clinical Research
Fort Lauderdale, Florida, United States
Waterway Research
Miami, Florida, United States
Valencia Medical and Research Center
Miami, Florida, United States
IMIC, Inc
Miami, Florida, United States
Harmony Clinical Research, Inc - North Miami Beach
Miami Beach, 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
Treasure Valley Medical Research
Boise, Idaho, United States
GI Alliance - Glenview, IL
Glenview, Illinois, United States
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Evanston Premier Healthcare Research LLC
Skokie, Illinois, United States
DelRicht Clinical Research - Indianapolis
Indianapolis, Indiana, United States
DelRicht Clinical Research - Overland Park
Overland Park, Kansas, United States
Tekton Research - Wichita, KS
Wichita, 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
University of Michigan Health System
Ann Arbor, Michigan, 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
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 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
Accellacare of Cary
Cary, North Carolina, United States
Delricht Clinical Research - Badmus
Charlotte, North Carolina, United States
Coastal Research Institute, LLC
Fayetteville, 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
Accellacare of Raleigh
Raleigh, North Carolina, United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, United States
Accellacare of Salisbury
Salisbury, North Carolina, United States
Accellacare of Piedmont HealthCare
Statesville, North Carolina, United States
Accellacare of Winston-Salem, Triad Neurological Associates
Winston-Salem, North Carolina, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Cleveland Clinic
Cleveland, Ohio, 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
Accellacare of Knoxville
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc - Memphis
Memphis, 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
Texas Gastro Consultants
Tomball, Texas, United States
Advanced Research Institute - Ogden
Ogden, Utah, United States
Wasatch Clinical Research, LLC
Salt Lake City, 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