A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
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)
1 other identifier
interventional
186
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 22, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
October 15, 2019
CompletedOctober 15, 2019
September 1, 2019
7 months
April 20, 2011
August 15, 2019
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
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.
Baseline and Week 4
Secondary Outcomes (1)
Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
baseline and week 4
Study Arms (4)
Placebo
PLACEBO COMPARATORCapsule that is identical in size and color to other treatments
Low Dose
EXPERIMENTAL10 mg capsule of tenapanor
Mid Dose
EXPERIMENTAL30 mg capsule of tenapanor
High Dose
EXPERIMENTAL100 mg capsule of tenapanor
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardelyxlead
Study Sites (16)
Ardelyx Investigational Site
San Diego, California, 92108, United States
Ardelyx Investigational Site
Jupiter, Florida, 33458, United States
Ardelyx Investigational Site
Pinellas Park, Florida, 33782, United States
Ardelyx Investigational Site
Rockford, Illinois, 61107, United States
Ardelyx Investigational Site
Mission, Kansas, 66202, United States
Ardelyx Investigational Site
Monroe, Louisiana, 71201, United States
Ardelyx Investigational Site
Annapolis, Maryland, 21401, United States
Ardelyx Investigational Site
Chesterfield, Michigan, 48047, United States
Ardelyx Investigational Site
St Louis, Missouri, 63128, United States
Ardelyx Investigational Site
Brooklyn, New York, 11214, United States
Ardelyx Investigational Site
Greensboro, North Carolina, 27408, United States
Ardelyx Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Ardelyx Investigational Site
Simpsonville, South Carolina, 29681, United States
Ardelyx Investigational Site
Bristol, Tennessee, 37620, United States
Ardelyx Investigational Site
Ogden, Utah, 84405, United States
Ardelyx Investigational Site
Lynchburg, Virginia, 24502, United States
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Development Officer
- Organization
- Ardelyx
Study Officials
- STUDY CHAIR
David P Rosenbaum, Ph.D.
Ardelyx
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 22, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
October 15, 2019
Results First Posted
October 15, 2019
Record last verified: 2019-09