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

NCT07382167 | Recruiting Phase 3 FDA Drug

• 1 other identifier: TEN-03-301
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 79

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)

Keywords

CIC

Outcome Measures

Primary Outcomes (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

  12 Weeks

Secondary Outcomes (5)

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

  12 Weeks

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

  12 Weeks

• Change from baseline in spontaneous bowel movement (SBM) frequency

  12 Weeks

• Change from baseline in stool consistency

  12 Weeks

• Change from baseline in stool straining

  12 Weeks

Study Arms (4)

Tenapanor 5 mg BID

EXPERIMENTAL

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

Drug: Tenapanor 5 mg BID

Tenapanor 25 mg BID

EXPERIMENTAL

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

Drug: Tenapanor 25 mg BID

Tenapanor 50 mg BID

EXPERIMENTAL

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

Drug: Tenapanor 50 mg BID

Placebo Comparator

PLACEBO COMPARATOR

Patients will be randomized to receive matching placebo twice daily.

Drug: Placebo

Interventions

Tenapanor 5 mg BID DRUG

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

Tenapanor 5 mg BID

Tenapanor 25 mg BID DRUG

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

Tenapanor 25 mg BID

Tenapanor 50 mg BID DRUG

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

Tenapanor 50 mg BID

Placebo DRUG

Patients will receive matching placebo BID

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (79)

Arizona Liver Health - Chandler

Chandler, Arizona, 85225, United States

RECRUITING

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

RECRUITING

Arkansas Gastroenterology - North Little Rock

North Little Rock, Arkansas, 72117, United States

RECRUITING

Hope Clinical Research - Canoga Park

Canoga Park, California, 91303, United States

RECRUITING

GW Research Inc.

Chula Vista, California, 91010, United States

RECRUITING

Erick H. Alayo Medical Corporation

Chula Vista, California, 91910, United States

RECRUITING

310 Clinical Research

Inglewood, California, 90301, United States

RECRUITING

Om Research LLC

Lancaster, California, 93534, United States

RECRUITING

Clinical Trials Research

Lincoln, California, 95648, United States

RECRUITING

Paragon Rx Clinical, Inc. - Santa Ana

Santa Ana, California, 92703, United States

RECRUITING

Rocky Mountain Gastroenterology (RMG) - Littleton

Lakewood, Colorado, 80228, United States

RECRUITING

Proactive Clinical Research

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Valencia Medical and Research Center

Miami, Florida, 33174, United States

RECRUITING

IMIC, Inc

Miami, Florida, 33176, United States

RECRUITING

Suncoast Clinical Research, Inc. - New Port Richey

New Port Richey, Florida, 34652, United States

RECRUITING

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

RECRUITING

Harmony Clinical Research - Orlando

Orange City, Florida, 32763, United States

RECRUITING

Suncoast Clinical Research, Inc. - Palm Harbor

Palm Harbor, Florida, 34684, United States

RECRUITING

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

RECRUITING

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

RECRUITING

DelRicht Clinical Research - Atlanta

Atlanta, Georgia, 30329, United States

RECRUITING

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia, 30060, United States

RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

RECRUITING

Elite Clinical Trials-Idaho

Blackfoot, Idaho, 83221, United States

RECRUITING

Clinical Investigation Specialists, Inc

Gurnee, Illinois, 60031, United States

RECRUITING

DelRicht Clinical Research - Indianapolis

Indianapolis, Indiana, 46202, United States

RECRUITING

DelRicht Clinical Research - Overland Park

Overland Park, Kansas, 66209, United States

RECRUITING

DelRicht Clinical Research - Louisville

Louisville, Kentucky, 40205, United States

RECRUITING

Tandem Clinical Research GI - Houma

Houma, Louisiana, 70363, United States

RECRUITING

DelRicht Clinical Research - Covington

Mandeville, Louisiana, 70471, United States

RECRUITING

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

RECRUITING

DelRicht Clinical Research - New Orleans

New Orleans, Louisiana, 70115, United States

RECRUITING

DelRicht Clinical Research - Prairieville

Prairieville, Louisiana, 70769, United States

RECRUITING

Delta Research Partners of West Monroe, LLC

West Monroe, Louisiana, 71291, United States

RECRUITING

Woodholme Gastroenterology

Glen Burnie, Maryland, 21061, United States

RECRUITING

Elixia SISU BHR - Sprinfield

Springfield, Massachusetts, 01103, United States

RECRUITING

Bay State Clinical Trials

Watertown, Massachusetts, 02472, United States

RECRUITING

DelRicht Clinical Research - Gulfport

Gulfport, Mississippi, 39503, United States

RECRUITING

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

RECRUITING

DelRicht Clinical Research - Springfield

Springfield, Missouri, 65807, United States

RECRUITING

St. Charles Clinical Research

St Louis, Missouri, 63141, United States

RECRUITING

DelRicht Clinical Research - Town and Country

Town and Country, Missouri, 63017, United States

RECRUITING

Gastrointestinal Associates LLP

Columbia Falls, Montana, 65201, United States

RECRUITING

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

RECRUITING

Digestive Disease Specialists

Las Vegas, Nevada, 89128, United States

RECRUITING

Advanced Research Institute - Reno

Reno, Nevada, 89511, United States

RECRUITING

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

Jackson, New Jersey, 08724, United States

RECRUITING

Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons

Somers Point, New Jersey, 08244, United States

RECRUITING

Albuquerque Clinical Trials (ACT)

Albuquerque, New Mexico, 87102, United States

RECRUITING

NY Scientific

Brooklyn, New York, 11235, United States

RECRUITING

Drug Trials America

Hartsdale, New York, 10530, United States

RECRUITING

Delricht Clinical Research - Badmus

Charlotte, North Carolina, 28210, United States

RECRUITING

Peters Medical Research

High Point, North Carolina, 27260, United States

RECRUITING

Lucas Research - Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, United States

RECRUITING

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

RECRUITING

Remington Davis, Inc.

Columbus, Ohio, 43215, United States

RECRUITING

Hometown Urgent Care and Research - Huber Heights

Huber Heights, Ohio, 45424, United States

RECRUITING

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060, United States

RECRUITING

DelRicht Clinical Research - Tulsa

Tulsa, Oklahoma, 74133, United States

RECRUITING

Tekton Research - Yukon, OK

Yukon, Oklahoma, 73099, United States

RECRUITING

Advanced Research Institute - Portland

Tigard, Oregon, 97223, United States

RECRUITING

DelRicht Clinical Research - Charleston

Charleston, South Carolina, 29407, United States

RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

RECRUITING

Accellacare of Bristol

Bristol, Tennessee, 37620, United States

RECRUITING

DelRicht Clinical Research - Nashville

Hendersonville, Tennessee, 37075, United States

RECRUITING

New Phase Research & Development - Knoxville

Knoxville, Tennessee, 37909, United States

RECRUITING

Quality Medical Research, PLLC

Nashville, Tennessee, 37211, United States

RECRUITING

Zenos Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

EPIC Medical Research

DeSoto, Texas, 75115, United States

RECRUITING

3A Research

El Paso, Texas, 79925, United States

RECRUITING

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

North Richland Hills, Texas, 76180, United States

RECRUITING

LinQ Research, LLC

Pearland, Texas, 77584, United States

RECRUITING

DelRicht Clinical Research - McKinney

Prosper, Texas, 75078, United States

RECRUITING

Sun Research Institute

San Antonio, Texas, 78215, United States

RECRUITING

Advanced Research Institute - Ogden

Ogden, Utah, 84405, United States

RECRUITING

Advanced Research Institute - Sandy

Sandy City, Utah, 84092, United States

RECRUITING

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

RECRUITING

Health Research of Hampton Roads, Inc. - Newport News

Newport News, Virginia, 23606, United States

RECRUITING

DelRicht Clinical Research - Vienn

Vienna, Virginia, 22182, United States

RECRUITING

MeSH Terms

Interventions

tenapanor; BID protein, human

Study Officials

• Susan Edelstein, PhD

  Ardelyx Inc

  STUDY DIRECTOR

Central Study Contacts

Jocelyn Tabora

CONTACT

510-745-1724; jtabora@ardelyx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): June 4, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (79)