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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)

Primary Purpose

Constipation Predominant Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RDX5791
Sponsored by
Ardelyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation Predominant Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site
  • Ardelyx Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Low Dose

Mid Dose

High Dose

Arm Description

Capsule that is identical in size and color to other treatments

10 mg capsule of tenapanor

30 mg capsule of tenapanor

100 mg capsule of tenapanor

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Spontaneous Bowel Movement (SBM) Frequency Change From Baseline

Full Information

First Posted
April 20, 2011
Last Updated
September 25, 2019
Sponsor
Ardelyx
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1. Study Identification

Unique Protocol Identification Number
NCT01340053
Brief Title
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation Predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule that is identical in size and color to other treatments
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
10 mg capsule of tenapanor
Arm Title
Mid Dose
Arm Type
Experimental
Arm Description
30 mg capsule of tenapanor
Arm Title
High Dose
Arm Type
Experimental
Arm Description
100 mg capsule of tenapanor
Intervention Type
Drug
Intervention Name(s)
RDX5791
Intervention Description
Capsule, QD
Primary Outcome Measure Information:
Title
Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
Description
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.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
Time Frame
baseline and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Rosenbaum, Ph.D.
Organizational Affiliation
Ardelyx
Official's Role
Study Chair
Facility Information:
Facility Name
Ardelyx Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Ardelyx Investigational Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Ardelyx Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Ardelyx Investigational Site
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Ardelyx Investigational Site
City
Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Ardelyx Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Ardelyx Investigational Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Ardelyx Investigational Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Ardelyx Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Ardelyx Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Ardelyx Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Ardelyx Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Ardelyx Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Ardelyx Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Ardelyx Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Ardelyx Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ardelyx.com
Description
Related Info

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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)

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