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A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340053
Recruitment Status : Completed
First Posted : April 22, 2011
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Information provided by (Responsible Party):

Brief Summary:

This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial.

The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.

Condition or disease Intervention/treatment Phase
Constipation Predominant Irritable Bowel Syndrome Drug: RDX5791 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of RDX5791 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Placebo Comparator: Placebo
Capsule that is identical in size and color to other treatments
Drug: RDX5791
Capsule, QD

Experimental: Low Dose
10 mg capsule of tenapanor
Drug: RDX5791
Capsule, QD

Experimental: Mid Dose
30 mg capsule of tenapanor
Drug: RDX5791
Capsule, QD

Experimental: High Dose
100 mg capsule of tenapanor
Drug: RDX5791
Capsule, QD

Primary Outcome Measures :
  1. Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline [ Time Frame: Baseline and Week 4 ]
    Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.

Secondary Outcome Measures :
  1. Spontaneous Bowel Movement (SBM) Frequency Change From Baseline [ Time Frame: baseline and week 4 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject meets Rome III criteria for IBS-C
  • If > 50 years old, colonoscopy evaluation within 10 years
  • All ages, negative colonoscopy if any "warning symptoms"
  • Active disease during 2-week screening period
  • Compliant with IVRS

Exclusion Criteria:

  • Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria
  • Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
  • Use of medications that are known to affect stool consistency
  • Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340053

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United States, California
Ardelyx Investigational Site
San Diego, California, United States, 92108
United States, Florida
Ardelyx Investigational Site
Jupiter, Florida, United States, 33458
Ardelyx Investigational Site
Pinellas Park, Florida, United States, 33782
United States, Illinois
Ardelyx Investigational Site
Rockford, Illinois, United States, 61107
United States, Kansas
Ardelyx Investigational Site
Mission, Kansas, United States, 66202
United States, Louisiana
Ardelyx Investigational Site
Monroe, Louisiana, United States, 71201
United States, Maryland
Ardelyx Investigational Site
Annapolis, Maryland, United States, 21401
United States, Michigan
Ardelyx Investigational Site
Chesterfield, Michigan, United States, 48047
United States, Missouri
Ardelyx Investigational Site
Saint Louis, Missouri, United States, 63128
United States, New York
Ardelyx Investigational Site
Brooklyn, New York, United States, 11214
United States, North Carolina
Ardelyx Investigational Site
Greensboro, North Carolina, United States, 27408
United States, Oklahoma
Ardelyx Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Ardelyx Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Ardelyx Investigational Site
Bristol, Tennessee, United States, 37620
United States, Utah
Ardelyx Investigational Site
Ogden, Utah, United States, 84405
United States, Virginia
Ardelyx Investigational Site
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
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Study Chair: David P Rosenbaum, Ph.D. Ardelyx
Additional Information:
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Responsible Party: Ardelyx Identifier: NCT01340053    
Other Study ID Numbers: RDX5791-201
First Posted: April 22, 2011    Key Record Dates
Results First Posted: October 15, 2019
Last Update Posted: October 15, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases