A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Ardelyx · NCT07382167
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 692
- US sites recruiting
- 109
- Study start
- January 13, 2026
- Record last updated
- June 4, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Tenapanor 5 mg BID; Tenapanor 25 mg BID; Tenapanor 50 mg BID; Placebo
Conditions: Chronic Idiopathic Constipation (CIC)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Recruiting US locations
G & L Research, LLC
Foley, AL 36535
Site contact: Christine Fuller · 251-943-2980 · glresearch5@gmail.com
The Center for Clinical Trials
Saraland, AL 36571
Site contact: JoAnn Ladner · 228-388-3112 · Joanne@thecenterforclinicaltrials.com
Arizona Liver Health - Chandler
Chandler, AZ 85225
Site contact: Reichard Ruiz · rruiz@azclinicaltrials.com
Elite Clinical Studies
Phoenix, AZ 85018
Site contact: Evette San Miguel · 602-788-3437 · Evette@eliteclinicalstudies.com
Clinical Research Institute of Arizona, LLC
Sun City West, AZ 85375
Site contact: Jamie Foreman · 623-223-1580 · jforeman@criofaz.com
Del Sol Research Management, LLC
Tucson, AZ 85715
Site contact: Maria Gallegos · 520-481-8464 · mgallegos@delsolresearch.com
Arkansas Gastroenterology - North Little Rock
North Little Rock, AR 72117
Site contact: Courtney Voss · 501-945-9300 · courtney@arkgi.net
Hope Clinical Research - Canoga Park
Canoga Park, CA 91303
Site contact: Anitha Roobalingam · aroobalingam@hopeclinical.com
GW Research Inc.
Chula Vista, CA 91010
Site contact: Jason Colia · 619-585-8882 · jcolia@gwresearch.net
Erick H. Alayo Medical Corporation
Chula Vista, CA 91910
Site contact: Marilyn Rodriguez · 619-382-3315 · marilyn@gastrosb.com
310 Clinical Research
Inglewood, CA 90301
Site contact: Indira Mohabir · 310-878-2636 · imohabir@allianceclinicalnetwork.com
Om Research LLC
Lancaster, CA 93534
Site contact: Guadalupe Barragan · gbarragan@omclinicaltrials.com
Clinical Trials Research
Lincoln, CA 95648
Site contact: Leesa Koskela · 916-434-8230 · leesa@ctrsites.com
Acclaim Clinical Research
San Diego, CA 92120
Site contact: Sandra Nissa · snissan@allianceclinicalnetwork.com
San Jose Gastroenterology
San Jose, CA 95128
Site contact: Charitha Ratakonda · cratakonda@jointopo.com
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, CA 92703
Site contact: Thy Tran · Thy.Tran@prxclinical.com
Advanced Research Institute - Denver
Denver, CO 80218
Site contact: Alexandra Mandy · 303-353-2660 · alexandra@advresearch.org
Rocky Mountain Gastroenterology (RMG) - Littleton
Lakewood, CO 80228
Site contact: Emily Hager · 303-722-8987 · rmg@jointopo.com
Tekton Research - Longmont, CO
Longmont, CO 80501
Site contact: Vanessa Sutton · vanessa.sutton@tektonresearch.com
Proactive Clinical Research
Fort Lauderdale, FL 33308
Site contact: Naila Pelegrin · 954-938-2843 · npelegrin@proactivecr.com
Waterway Research
Miami, FL 33155
Site contact: Claudia Cuellar Ramos · ccramos@waterwayresearch.com
Valencia Medical and Research Center
Miami, FL 33174
Site contact: Yamie Chaviano · ychaviano@valenciamedresearch.com
IMIC, Inc
Miami, FL 33176
Site contact: Teresa Valencia · teresa@roviaclinical.com
Harmony Clinical Research, Inc - North Miami Beach
Miami Beach, FL 33162
Site contact: Nichole Ramirez · nramirez@hcresearchfl.com
Suncoast Clinical Research, Inc. - New Port Richey
New Port Richey, FL 34652
Site contact: Mark Mason · 727-849-4131 · mmason@suncoastclinicalresearch.com
Sensible Healthcare, LLC
Ocoee, FL 34761
Site contact: Jenny Kuerth · 407-654-2724 · jkuerth@sensiblehealthcare.net
Harmony Clinical Research - Orlando
Orange City, FL 32763
Site contact: Jennifer Pages · 305-957-7200 · jpages@clinmastery.com
Suncoast Clinical Research, Inc. - Palm Harbor
Palm Harbor, FL 34684
Site contact: Alayna Tiffany · 727-781-3655 · atiffany@suncoastclinicalresearch.com
Clinical Research Center of Florida
Pompano Beach, FL 33060
Site contact: Zachary Weiss · zachary@floridacrc.com
Agile Clinical Research Trials, LLC
Atlanta, GA 30328
Site contact: Madeline Mendoza · mmendoza@agilecrt.com
DelRicht Clinical Research - Atlanta
Atlanta, GA 30329
Site contact: Maddie LaQua · 504-336-2667 · mlaqua@delricht.com
Gastrointestinal Specialists of Georgia PC
Marietta, GA 30060
Site contact: Octavia Nichols · 678-819-4237 · Onichols@gigeorgia.com
North Georgia Clinical Research
Woodstock, GA 30189
Site contact: Shelby Satterwhite · shelby.satterwhite@ngclinicalresearch.com
Elite Clinical Trials-Idaho
Blackfoot, ID 83221
Site contact: Berta Bates · 208-643-0006 · bbates.ect@gmail.com
Treasure Valley Medical Research
Boise, ID 83706
Site contact: Rachel Dugdale · rdugdale@tvmedresearch.com
GI Alliance - Glenview, IL
Glenview, IL 60026
Site contact: Ansharah Asif · ansharah.asif@gialliance.com
Clinical Investigation Specialists, Inc
Gurnee, IL 60031
Site contact: Patrycja Kalwajtys · pkalwajtys@cisresearch.com
Southwest Gastroenterology
Oak Lawn, IL 60453
Site contact: Harish Kumar Gundlapalli · harish.gundlapalli@avicennaclinical.com
Evanston Premier Healthcare Research LLC
Skokie, IL 60077
Site contact: Galina Tsirulnik · galina@evanstonpremier.com
DelRicht Clinical Research - Indianapolis
Indianapolis, IN 46202
Site contact: Hailey Hunziker · 504-336-2667 · hhunziker@delricht.com
DelRicht Clinical Research - Overland Park
Overland Park, KS 66209
Site contact: Anthony Alioto · 913-391-7188 · aalioto@delricht.com
Tekton Research - Wichita, KS
Wichita, KS 67218
Site contact: Brooke Carr · brooke.carr@tektonresearch.com
DelRicht Clinical Research - Louisville
Louisville, KY 40205
Site contact: Jessi Walker · jwalker@delricht.com
Tandem Clinical Research GI - Houma
Houma, LA 70363
Site contact: Jahel Osornio · 985-219-6501 · josornio@tandemclinicalresearch.com
DelRicht Clinical Research - Covington
Mandeville, LA 70471
Site contact: Brittany Bolton · 225-412-0316 · bbolton@delricht.com
Tandem Clinical Research
Marrero, LA 70072
Site contact: Meg Muli · 504-934-8424 · MMuli@tandemclinicalresearch.com
DelRicht Clinical Research - New Orleans
New Orleans, LA 70115
Site contact: Emily Krambeck · 504-336-2667 · ekrambeck@delricht.com
DelRicht Clinical Research - Prairieville
Prairieville, LA 70769
Site contact: Brittany Bolton · 225-412-0316 · bbolton@delricht.com
Delta Research Partners of West Monroe, LLC
West Monroe, LA 71291
Site contact: Jennifer Davidson · 318-538-0085 · jennifer.davidson@roviaclinical.com
Woodholme Gastroenterology
Glen Burnie, MD 21061
Site contact: Amy Martin · woodholme@jointopo.com
Elixia SISU BHR - Sprinfield
Springfield, MA 01103
Site contact: Hannah Sheets · 413-305-1144 · hannah.sheets@elixiahealth.com
Bay State Clinical Trials
Watertown, MA 02472
Site contact: Tina LaFleur · 617-923-0328 · tmlbsct@gmail.com
University of Michigan Health System
Ann Arbor, MI 48109
Site contact: Benson Hang · Behang@med.umich.edu
DelRicht Clinical Research - Gulfport
Gulfport, MS 39503
Site contact: Amber Laque · 504-336-2667 · alaque@delricht.com
Kansas City Research Institute
Kansas City, MO 64131
Site contact: Taleah Brown · Taleah.brown@kcri.health
DelRicht Clinical Research - Springfield
Springfield, MO 65807
Site contact: Austin Christian · 504-336-2667 · achristian@delricht.com
St. Charles Clinical Research
St Louis, MO 63141
Site contact: Kelly Moushey · 636-477-6366 · k.moushey@stcharlesclinicalresearch.com
DelRicht Clinical Research - Town and Country
Town and Country, MO 63017
Site contact: Nicole Huddleston · 504-336-2667 · nhuddleston@delricht.com
Gastrointestinal Associates LLP
Columbia Falls, MT 65201
Site contact: Coby Ayers · 573-740-0800 · Coby.Ayers@objective.health
Jubilee Clinical Research, Inc.
Las Vegas, NV 89106
Site contact: Matthew O'Sullivan · 702-631-5000 · mosullivan@pinnacleresearch.com
+ 49 more on the official record.
Study contacts (from the official record)
- Marica Tambongco · (617) 875-7968 · mtambongco@ardelyx.com