A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
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
Interventions
Tenapanor 5 mg BID
Tenapanor 25 mg BID
Tenapanor 50 mg BID
Placebo
Conditions
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