A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2)

April 10, 2020 updated by: Ardelyx

A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

593

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Ardelyx Investigative Site 257
      • Foley, Alabama, United States, 36535
        • Ardelyx Investigative Site 200
      • Huntsville, Alabama, United States, 35801
        • Ardelyx Investigative Site 103
      • Huntsville, Alabama, United States, 35802
        • Ardelyx Investigative Site 100
      • Huntsville, Alabama, United States, 35801
        • Ardelyx Investigative Site 244
      • Huntsville, Alabama, United States, 35801
        • Ardelyx Investigative Site 251
      • Saraland, Alabama, United States, 36571
        • Ardelyx Investigative Site 209
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Ardelyx Investigative Site 210
      • Phoenix, Arizona, United States, 85018
        • Ardelyx Investigative Site 296
      • Tucson, Arizona, United States, 85704
        • Ardelyx Investigative Site 269
      • Tucson, Arizona, United States, 85710
        • Ardelyx Investigative Site 256
    • Arkansas
      • Conway, Arkansas, United States, 72034
        • Ardelyx Investigative Site 292
      • Little Rock, Arkansas, United States, 72212
        • Ardelyx Investigative Site 122
    • California
      • Anaheim, California, United States, 92801
        • Ardelyx Investigative Site 163
      • Canoga Park, California, United States, 91303
        • Ardelyx Investigative Site 105
      • Chula Vista, California, United States, 91910
        • Ardelyx Investigative Site 143
      • Encino, California, United States, 91436
        • Ardelyx Investigative Site 147
      • La Mesa, California, United States, 91942
        • Ardelyx Investigative Site 297
      • La Mirada, California, United States, 90638
        • Ardelyx Investigative Site 284
      • Lomita, California, United States, 90717
        • Ardelyx Investigative Site 107
      • Long Beach, California, United States, 90807
        • Ardelyx Investigative Site 165
      • Orange, California, United States, 92868
        • Ardelyx Investigative Site 211
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Ardelyx Investigative Site 233
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Ardelyx Investigative Site 212
    • Florida
      • Brandon, Florida, United States, 33511
        • Ardelyx Investigative Site 176
      • Cutler Bay, Florida, United States, 33157
        • Ardelyx Investigative Site 178
      • Hialeah, Florida, United States, 33012
        • Ardelyx Investigative Site 136
      • Hialeah, Florida, United States, 33016
        • Ardelyx Investigative Site 130
      • Lynn Haven, Florida, United States, 32444
        • Ardelyx Investigative Site 191
      • Miami, Florida, United States, 33186
        • Ardelyx Investigative Site 106
      • Miami, Florida, United States, 33144
        • Ardelyx Investigative Site 288
      • Miami Lakes, Florida, United States, 33014
        • Ardelyx Investigative Site 127
      • Orlando, Florida, United States, 32803
        • Ardelyx Investigative Site 179
      • Tampa, Florida, United States, 33607
        • Ardelyx Investigative Site 290
      • West Palm Beach, Florida, United States, 33409
        • Ardelyx Investigative Site 254
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Ardelyx Investigative Site 138
      • Atlanta, Georgia, United States, 30342
        • Ardelyx Investigative Site 148
      • Atlanta, Georgia, United States, 30342
        • Ardelyx Investigative Site 253
      • Decatur, Georgia, United States, 30032
        • Ardelyx Investigative Site 272
      • Decatur, Georgia, United States, 30033
        • Ardelyx Investigative Site 229
      • Marietta, Georgia, United States, 30060
        • Ardelyx Investigative Site 250
      • Norcross, Georgia, United States, 30071
        • Ardelyx Investigative Site 137
      • Savannah, Georgia, United States, 31406
        • Ardelyx Investigative Site 213
      • Snellville, Georgia, United States, 30078
        • Ardelyx Investigative Site 124
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Ardelyx Investigative Site 268
      • Evergreen Park, Illinois, United States, 60805
        • Ardelyx Investigative Site 227
      • Hoffman Estates, Illinois, United States, 60169
        • Ardelyx Investigative Site 291
      • Oak Lawn, Illinois, United States, 60453
        • Ardelyx Investigative Site 202
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Ardelyx Investigative Site 218
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Ardelyx Investigative Site 158
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Ardelyx Investigative Site 270
      • Marrero, Louisiana, United States, 70072
        • Ardelyx Investigative Site 214
      • Metairie, Louisiana, United States, 70006
        • Ardelyx Investigative Site 154
      • Shreveport, Louisiana, United States, 71103
        • Ardelyx Investigative Site 195
    • Maine
      • Bangor, Maine, United States, 04401
        • Ardelyx Investigative Site 271
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Ardelyx Investigative Site 160
      • Towson, Maryland, United States, 21204
        • Ardelyx Investigative Site 255
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Ardelyx Investigative Site 267
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Ardelyx Investigative Site 260
      • Buckley, Michigan, United States, 49620
        • Ardelyx Investigative Site 283
      • Flint, Michigan, United States, 48504
        • Ardelyx Investigative Site 239
      • Troy, Michigan, United States, 48098
        • Ardelyx Investigative Site 168
      • Wyoming, Michigan, United States, 49519
        • Ardelyx Investigative Site 216
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • Ardelyx Investigative Site 221
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Ardelyx Investigative Site 282
      • Saint Louis, Missouri, United States, 63042
        • Ardelyx Investigative Site 228
    • Montana
      • Billings, Montana, United States, 59102
        • Ardelyx Investigative Site 156
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Ardelyx Investigative Site 182
    • New Jersey
      • Vineland, New Jersey, United States, 08360
        • Ardelyx Investigative Site 175
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Ardelyx Investigative Site 222
      • Albuquerque, New Mexico, United States, 87106
        • Ardelyx Investigative Site 264
    • New York
      • Brooklyn, New York, United States, 11206
        • Ardelyx Investigative Site 230
      • Great Neck, New York, United States, 11023
        • Ardelyx Investigative Site 170
      • New Hyde Park, New York, United States, 11040
        • Ardelyx Investigative Site 203
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Ardelyx Investigative Site 205
      • Greensboro, North Carolina, United States, 27408
        • Ardelyx Investigative Site 190
      • Hickory, North Carolina, United States, 28601
        • Ardelyx Investigative Site 194
      • Wilmington, North Carolina, United States, 28401
        • Ardelyx Investigative Site 285
    • Ohio
      • Beavercreek, Ohio, United States, 45432
        • Ardelyx Investigative Site 172
      • Cincinnati, Ohio, United States, 45234
        • Ardelyx Investigative Site 201
      • Cincinnati, Ohio, United States, 45212
        • Ardelyx Investigative Site 204
      • Dayton, Ohio, United States, 45429
        • Ardelyx Investigative Site 173
      • Franklin, Ohio, United States, 45005
        • Ardelyx Investigative Site 208
      • Huber Heights, Ohio, United States, 45424
        • Ardelyx Investigative Site 171
      • Lima, Ohio, United States, 45806
        • Ardelyx Investigative Site 219
      • Wadsworth, Ohio, United States, 44281
        • Ardelyx Investigative Site 232
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Ardelyx Investigative Site 236
      • Tulsa, Oklahoma, United States, 74135
        • Ardelyx Investigative Site 273
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Ardelyx Investigative Site 220
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Ardelyx Investigative Site 248
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Ardelyx Investigative Site 252
      • Gaffney, South Carolina, United States, 29341
        • Ardelyx Investigative Site 265
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Ardelyx Investigative Site 246
      • Sioux Falls, South Dakota, United States, 57108
        • Ardelyx Investigative Site 261
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Ardelyx Investigative Site 217
      • Franklin, Tennessee, United States, 37064
        • Ardelyx Investigative Site 121
      • Hermitage, Tennessee, United States, 37076
        • Ardelyx Investigative Site 189
      • Jackson, Tennessee, United States, 38305
        • Ardelyx Investigative Site 133
      • Knoxville, Tennessee, United States, 37909
        • Ardelyx Investigative Site 109
      • Memphis, Tennessee, United States, 38119
        • Ardelyx Investigative Site 266
      • Nashville, Tennessee, United States, 37211
        • Ardelyx Investigative Site 235
      • Spring Hill, Tennessee, United States, 37174
        • Ardelyx Investigative Site 279
    • Texas
      • Channelview, Texas, United States, 77530
        • Ardelyx Investigative Site 180
      • Houston, Texas, United States, 77079
        • Ardelyx Investigative Site 185
      • Houston, Texas, United States, 77036
        • Ardelyx Investigative Site 286
      • Houston, Texas, United States, 77043
        • Ardelyx Investigative Site 262
      • McKinney, Texas, United States, 75071
        • Ardelyx Investigative Site 113
      • Port Arthur, Texas, United States, 77640
        • Ardelyx Investigative Site 263
      • San Antonio, Texas, United States, 78229
        • Ardelyx Investigative Site 181
      • San Antonio, Texas, United States, 78258
        • Ardelyx Investigative Site 186
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Ardelyx Investigative Site 167
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Ardelyx Investigative Site 231
      • Norfolk, Virginia, United States, 23502
        • Ardelyx Investigative Site 249
      • Petersburg, Virginia, United States, 23805
        • Ardelyx Investigative Site 258
      • Virginia Beach, Virginia, United States, 23462
        • Ardelyx Investigative Site 245
    • Washington
      • Spokane, Washington, United States, 99202
        • Ardelyx Investigative Site 242
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Ardelyx Investigative Site 195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: 50mg BID
Tenapanor, 50mg BID (100mg total)
Drug: Tenapanor
Other Names:
  • RDX5791
  • AZD1722

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Overall Response for 6 Out of 12 Weeks
Time Frame: First 12 weeks
An overall responder is defined as a weekly responder for the first 6/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
First 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks
Time Frame: First 12 weeks
An overall CSBM responder is defined as a weekly responder for the first 6/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"
First 12 weeks
Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks
Time Frame: First 12 weeks
An overall abdominal pain responder is defined as a weekly responder for the first 6/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
First 12 weeks
Percentage of Subjects With Overall Response for 13 Out of 26 Weeks
Time Frame: 26 weeks
An overall responder is defined as a weekly responder for the first 13/26 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
26 weeks
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks
Time Frame: 26 weeks
An overall CSBM responder is defined as a weekly responder for the first 13/26 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"
26 weeks
Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks
Time Frame: 26 weeks
An overall abdominal pain responder is defined as a weekly responder for the first 13/26 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
26 weeks
Percentage of Subjects With Overall Response for 9 Out of 12 Weeks
Time Frame: First 12 weeks
An overall responder is defined as a weekly responder for the first 9/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
First 12 weeks
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks
Time Frame: First 12 weeks
An overall CSBM responder is defined as a weekly responder for the first 9/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"
First 12 weeks
Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks
Time Frame: First 12 weeks
An overall abdominal pain responder is defined as a weekly responder for the first 9/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.
First 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardelyx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEN-01-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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