Chronic Idiopathic Constipation (CIC) Clinical Trials

Find Chronic Idiopathic Constipation (CIC) Clinical Trials Near You

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

Status: Recruiting
Location: See all (109) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
G & L Research, LLC
RECRUITING
Foley
The Center for Clinical Trials
RECRUITING
Saraland
Arkansas
Arkansas Gastroenterology - North Little Rock
RECRUITING
North Little Rock
Arizona
Arizona Liver Health - Chandler
RECRUITING
Chandler
Elite Clinical Studies
RECRUITING
Phoenix
Clinical Research Institute of Arizona, LLC
RECRUITING
Sun City West
Del Sol Research Management, LLC
RECRUITING
Tucson
California
Hope Clinical Research - Canoga Park
RECRUITING
Canoga Park
Erick H. Alayo Medical Corporation
RECRUITING
Chula Vista
GW Research Inc.
RECRUITING
Chula Vista
310 Clinical Research
RECRUITING
Inglewood
Om Research LLC
RECRUITING
Lancaster
Clinical Trials Research
RECRUITING
Lincoln
Acclaim Clinical Research
RECRUITING
San Diego
San Jose Gastroenterology
RECRUITING
San Jose
Paragon Rx Clinical, Inc. - Santa Ana
RECRUITING
Santa Ana
Colorado
Advanced Research Institute - Denver
RECRUITING
Denver
Rocky Mountain Gastroenterology (RMG) - Littleton
RECRUITING
Lakewood
Tekton Research - Longmont, CO
RECRUITING
Longmont
Florida
Proactive Clinical Research
RECRUITING
Fort Lauderdale
IMIC, Inc
RECRUITING
Miami
Valencia Medical and Research Center
RECRUITING
Miami
Waterway Research
RECRUITING
Miami
Harmony Clinical Research, Inc - North Miami Beach
RECRUITING
Miami Beach
Suncoast Clinical Research, Inc. - New Port Richey
RECRUITING
New Port Richey
Sensible Healthcare, LLC
RECRUITING
Ocoee
Harmony Clinical Research - Orlando
RECRUITING
Orange City
Suncoast Clinical Research, Inc. - Palm Harbor
RECRUITING
Palm Harbor
Clinical Research Center of Florida
RECRUITING
Pompano Beach
Georgia
Agile Clinical Research Trials, LLC
RECRUITING
Atlanta
DelRicht Clinical Research - Atlanta
RECRUITING
Atlanta
Gastrointestinal Specialists of Georgia PC
RECRUITING
Marietta
North Georgia Clinical Research
RECRUITING
Woodstock
Idaho
Elite Clinical Trials-Idaho
RECRUITING
Blackfoot
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
GI Alliance - Glenview, IL
RECRUITING
Glenview
Clinical Investigation Specialists, Inc
RECRUITING
Gurnee
Southwest Gastroenterology
RECRUITING
Oak Lawn
Evanston Premier Healthcare Research LLC
RECRUITING
Skokie
Indiana
DelRicht Clinical Research - Indianapolis
RECRUITING
Indianapolis
Kansas
DelRicht Clinical Research - Overland Park
RECRUITING
Overland Park
Tekton Research - Wichita, KS
RECRUITING
Wichita
Kentucky
DelRicht Clinical Research - Louisville
RECRUITING
Louisville
Louisiana
Tandem Clinical Research GI - Houma
RECRUITING
Houma
DelRicht Clinical Research - Covington
RECRUITING
Mandeville
Tandem Clinical Research
RECRUITING
Marrero
DelRicht Clinical Research - New Orleans
RECRUITING
New Orleans
DelRicht Clinical Research - Prairieville
RECRUITING
Prairieville
Delta Research Partners of West Monroe, LLC
RECRUITING
West Monroe
Massachusetts
Elixia SISU BHR - Sprinfield
RECRUITING
Springfield
Bay State Clinical Trials
RECRUITING
Watertown
Maryland
Woodholme Gastroenterology
RECRUITING
Glen Burnie
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Missouri
Kansas City Research Institute
RECRUITING
Kansas City
DelRicht Clinical Research - Springfield
RECRUITING
Springfield
St. Charles Clinical Research
RECRUITING
St Louis
DelRicht Clinical Research - Town and Country
RECRUITING
Town And Country
Mississippi
DelRicht Clinical Research - Gulfport
RECRUITING
Gulfport
Montana
Gastrointestinal Associates LLP
RECRUITING
Columbia Falls
North Carolina
Accellacare of Cary
RECRUITING
Cary
Delricht Clinical Research - Badmus
RECRUITING
Charlotte
Coastal Research Institute, LLC
RECRUITING
Fayetteville
Peters Medical Research
RECRUITING
High Point
Lucas Research - Diabetes & Endocrinology Consultants, PC
RECRUITING
Morehead City
Accellacare of Raleigh
RECRUITING
Raleigh
Accellacare of Rocky Mount
RECRUITING
Rocky Mount
Accellacare of Salisbury
RECRUITING
Salisbury
Accellacare of Piedmont HealthCare
RECRUITING
Statesville
Accellacare of Winston-Salem, Triad Neurological Associates
RECRUITING
Winston-salem
North Dakota
Lillestol Research, LLC
RECRUITING
Fargo
New Jersey
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
RECRUITING
Jackson
Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons
RECRUITING
Somers Point
New Mexico
Albuquerque Clinical Trials (ACT)
RECRUITING
Albuquerque
Nevada
Digestive Disease Specialists
RECRUITING
Las Vegas
Excel Clinical Research
RECRUITING
Las Vegas
Jubilee Clinical Research, Inc.
RECRUITING
Las Vegas
Advanced Research Institute - Reno
RECRUITING
Reno
New York
NY Scientific
RECRUITING
Brooklyn
Drug Trials America
RECRUITING
Hartsdale
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Centricity Research Columbus Ohio Multispecialty
RECRUITING
Columbus
Remington Davis, Inc.
RECRUITING
Columbus
Hometown Urgent Care and Research - Huber Heights
RECRUITING
Huber Heights
Great Lakes Gastroenterology Research
RECRUITING
Mentor
Oklahoma
DelRicht Clinical Research - Tulsa
RECRUITING
Tulsa
Tekton Research - Yukon, OK
RECRUITING
Yukon
Oregon
Advanced Research Institute - Portland
RECRUITING
Tigard
South Carolina
DelRicht Clinical Research - Charleston
RECRUITING
Charleston
Coastal Carolina Research Center
RECRUITING
North Charleston
Tennessee
Accellacare of Bristol
RECRUITING
Bristol
DelRicht Clinical Research - Nashville
RECRUITING
Hendersonville
Accellacare of Knoxville
RECRUITING
Knoxville
New Phase Research & Development - Knoxville
RECRUITING
Knoxville
Clinical Neuroscience Solutions, Inc - Memphis
RECRUITING
Memphis
Quality Medical Research, PLLC
RECRUITING
Nashville
Texas
Zenos Clinical Research
RECRUITING
Dallas
EPIC Medical Research
RECRUITING
Desoto
3A Research
RECRUITING
El Paso
North Hills Medical Research Inc. (North Hills Family Medicine)
RECRUITING
North Richland Hills
LinQ Research, LLC
RECRUITING
Pearland
DelRicht Clinical Research - McKinney
RECRUITING
Prosper
Sun Research Institute
RECRUITING
San Antonio
Texas Gastro Consultants
RECRUITING
Tomball
Utah
Advanced Research Institute - Ogden
RECRUITING
Ogden
Wasatch Clinical Research, LLC
RECRUITING
Salt Lake City
Advanced Research Institute - Sandy
RECRUITING
Sandy City
Virginia
Charlottesville Medical Research Center, LLC
RECRUITING
Charlottesville
Health Research of Hampton Roads, Inc. - Newport News
RECRUITING
Newport News
DelRicht Clinical Research - Vienn
RECRUITING
Vienna
Contact Information
Primary
Marica Tambongco
mtambongco@ardelyx.com
(617) 875-7968
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2027-06-04
Participants
Target number of participants: 692
Treatments
Experimental: Tenapanor 5 mg BID
Patients will be randomized to receive 5 mg tenapanor twice daily.
Experimental: Tenapanor 25 mg BID
Patients will be randomized to receive 25 mg tenapanor twice daily.
Experimental: Tenapanor 50 mg BID
Patients will be randomized to receive 50 mg tenapanor twice daily.
Placebo_comparator: Placebo Comparator
Patients will be randomized to receive matching placebo twice daily.
Related Therapeutic Areas
Sponsors
Leads: Ardelyx

This content was sourced from clinicaltrials.gov