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A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

NCT ID: NCT02686138

Last Updated: 2020-04-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-10-31

Brief Summary

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This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose of Tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for a 26 week treatment period.

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Detailed Description

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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.

Conditions

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Constipation Predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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50mg BID

Tenapanor, 50mg BID (100mg total)

Group Type EXPERIMENTAL

Tenapanor

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Tenapanor

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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RDX5791 AZD1722

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ardelyx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David P Rosenbaum, Ph.D.

Role: STUDY_CHAIR

Ardelyx, Inc.

Locations

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Ardelyx Investigative Site 257

Dothan, Alabama, United States

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Ardelyx Investigative Site 200

Foley, Alabama, United States

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Ardelyx Investigative Site 103

Huntsville, Alabama, United States

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Ardelyx Investigative Site 244

Huntsville, Alabama, United States

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Ardelyx Investigative Site 251

Huntsville, Alabama, United States

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Huntsville, Alabama, United States

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Ardelyx Investigative Site 209

Saraland, Alabama, United States

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Ardelyx Investigative Site 210

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Ardelyx Investigative Site 269

Tucson, Arizona, United States

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Ardelyx Investigative Site 256

Tucson, Arizona, United States

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Ardelyx Investigative Site 292

Conway, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Ardelyx Investigative Site 105

Canoga Park, California, United States

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Ardelyx Investigative Site 143

Chula Vista, California, United States

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Encino, California, United States

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Ardelyx Investigative Site 297

La Mesa, California, United States

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Ardelyx Investigative Site 284

La Mirada, California, United States

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Lomita, California, United States

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Long Beach, California, United States

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Ardelyx Investigative Site 211

Orange, California, United States

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Ardelyx Investigative Site 233

Wheat Ridge, Colorado, United States

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Bristol, Connecticut, United States

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Brandon, Florida, United States

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Cutler Bay, Florida, United States

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Hialeah, Florida, United States

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Hialeah, Florida, United States

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Ardelyx Investigative Site 191

Lynn Haven, Florida, United States

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Ardelyx Investigative Site 288

Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Norcross, Georgia, United States

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Savannah, Georgia, United States

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Snellville, Georgia, United States

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Burr Ridge, Illinois, United States

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Evergreen Park, Illinois, United States

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Hoffman Estates, Illinois, United States

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Oak Lawn, Illinois, United States

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Evansville, Indiana, United States

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Madisonville, Kentucky, United States

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Mandeville, Louisiana, United States

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Marrero, Louisiana, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Annapolis, Maryland, United States

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Towson, Maryland, United States

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Brockton, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Buckley, Michigan, United States

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Flint, Michigan, United States

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Troy, Michigan, United States

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Wyoming, Michigan, United States

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Biloxi, Mississippi, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Las Vegas, Nevada, United States

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Vineland, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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New Hyde Park, New York, United States

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Fayetteville, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Wilmington, North Carolina, United States

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Beavercreek, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Franklin, Ohio, United States

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Huber Heights, Ohio, United States

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Lima, Ohio, United States

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Wadsworth, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Levittown, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Gaffney, South Carolina, United States

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Rapid City, South Dakota, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Franklin, Tennessee, United States

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Hermitage, Tennessee, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Spring Hill, Tennessee, United States

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Channelview, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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Port Arthur, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Petersburg, Virginia, United States

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Virginia Beach, Virginia, United States

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Ardelyx Investigative Site 242

Spokane, Washington, United States

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Ardelyx Investigative Site 195

Morgantown, West Virginia, United States

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Countries

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United States

References

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Lembo AJ, Friedenberg KA, Fogel RP, Edelstein S, Zhao S, Yang Y, Rosenbaum DP, Chey WD. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023 Nov;35(11):e14658. doi: 10.1111/nmo.14658. Epub 2023 Sep 5.

Reference Type DERIVED
PMID: 37668173 (View on PubMed)

Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.

Reference Type DERIVED
PMID: 33337659 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TEN-01-302

Identifier Type: -

Identifier Source: org_study_id

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