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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340053
First Posted: April 22, 2011
Last Update Posted: March 2, 2012
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.
Information provided by (Responsible Party):
Ardelyx
  Purpose

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 Intervention Phase
Constipation Predominant Irritable Bowel Syndrome Drug: RDX5791 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Ardelyx:

Primary Outcome Measures:
  • Complete Spontaneous Bowel Movement (CSBM) Frequency change from baseline [ Time Frame: weekly for 4 weeks ]

Secondary Outcome Measures:
  • Abdominal Pain change from baseline [ Time Frame: weekly for 4 weeks ]
  • Spontaneous Bowel Movement (SBM) Frequency change from baseline [ Time Frame: weekly for 4 weeks ]
  • Straining change from baseline [ Time Frame: weekly for 4 weeks ]
  • Bloating change from baseline [ Time Frame: weekly for 4 weeks ]
  • Adequate relief of IBS Symptoms [ Time Frame: 4 weeks ]

Enrollment: 186
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: RDX5791
Capsule, QD
Experimental: Low Dose Drug: RDX5791
Capsule, QD
Experimental: Mid Dose Drug: RDX5791
Capsule, QD
Experimental: High Dose Drug: RDX5791
Capsule, QD

  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01340053


Locations
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
St. 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
Ardelyx
Investigators
Study Chair: David P Rosenbaum, Ph.D. Ardelyx
  More Information

Additional Information:
Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT01340053     History of Changes
Other Study ID Numbers: RDX5791-201
First Submitted: April 20, 2011
First Posted: April 22, 2011
Last Update Posted: March 2, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases