A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
Launched by ARDELYX · Feb 15, 2016
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
During the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. Subjects will also record weekly assessments including: adequate relief of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Males or females aged 18 to 75 years, inclusive
- • Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
- • Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
- • Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
- • A colonoscopy based on AGA guidelines; every 10 years at ≥50 years old
- Exclusion Criteria:
- • Functional diarrhea as defined by Rome III criteria
- • IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
- • Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcinoid syndrome.
- • Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
- • Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
- • Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal) or renal impairment (serum creatinine \>2 mg/dL)
- • Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
- • Any surgery on the stomach, small intestine or colon, excluding appendectomy and cholecystectomy (unless within 60 days of screening visit)
About Ardelyx
Ardelyx is a biopharmaceutical company focused on developing innovative therapies for patients with gastrointestinal and renal diseases. With a commitment to addressing unmet medical needs, Ardelyx leverages its proprietary research platform to discover and advance novel drug candidates. The company’s pipeline includes treatments aimed at improving patient outcomes through targeted mechanisms of action, particularly in conditions such as irritable bowel syndrome and chronic kidney disease. Ardelyx emphasizes rigorous clinical development and collaboration with healthcare professionals to bring transformative solutions to market, ultimately enhancing the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Canoga Park, California, United States
Chula Vista, California, United States
Encino, California, United States
Lomita, California, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Norcross, Georgia, United States
Savannah, Georgia, United States
Snellville, Georgia, United States
Oak Lawn, Illinois, United States
Towson, Maryland, United States
Brockton, Massachusetts, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Vineland, New Jersey, United States
Great Neck, New York, United States
Fayetteville, North Carolina, United States
Beavercreek, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Huber Heights, Ohio, United States
Sioux Falls, South Dakota, United States
Franklin, Tennessee, United States
Hermitage, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Mckinney, Texas, United States
Norfolk, Virginia, United States
Dothan, Alabama, United States
Foley, Alabama, United States
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Saraland, Alabama, United States
Tucson, Arizona, United States
Conway, Arkansas, United States
Anaheim, California, United States
La Mesa, California, United States
La Mirada, California, United States
Long Beach, California, United States
Orange, California, United States
Wheat Ridge, Colorado, United States
Bristol, Connecticut, United States
Brandon, Florida, United States
Lynn Haven, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Burr Ridge, Illinois, United States
Evergreen Park, Illinois, United States
Hoffman Estates, Illinois, United States
Evansville, Indiana, United States
Madisonville, Kentucky, United States
Mandeville, Louisiana, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
Bangor, Maine, United States
Annapolis, Maryland, United States
Ann Arbor, Michigan, United States
Buckley, Michigan, United States
Flint, Michigan, United States
Troy, Michigan, United States
Wyoming, Michigan, United States
Biloxi, Mississippi, United States
Jefferson City, Missouri, United States
Saint Louis, Missouri, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
New Hyde Park, New York, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Franklin, Ohio, United States
Lima, Ohio, United States
Wadsworth, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Levittown, Pennsylvania, United States
East Providence, Rhode Island, United States
Columbia, South Carolina, United States
Gaffney, South Carolina, United States
Rapid City, South Dakota, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Spring Hill, Tennessee, United States
Channelview, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Port Arthur, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Petersburg, Virginia, United States
Virginia Beach, Virginia, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
Patients applied
Trial Officials
David P Rosenbaum, Ph.D.
Study Chair
Ardelyx, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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