A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C (T3MPO-1)

April 10, 2020 updated by: Ardelyx

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy 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 or placebo BID for 12 week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the 12-week treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation and complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping. Subjects will also record weekly assessments including: adequate relief of IBS severity, and constipation severity.

At the end of the 12-week treatment period, there will be a 4-week randomized withdrawal period in which subjects who complete the study in Tenapanor group will be randomized to either Tenapanor 50mg BID or placebo BID (1:1) and subjects who complete the study in the placebo group will be assigned to receive Tenapanor 50mg BID.

Study Type

Interventional

Enrollment (Actual)

606

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
      • Birmingham, Alabama, United States, 35216
        • Ardelyx Investigative Site 149
      • Birmingham, Alabama, United States, 35242
        • Ardelyx Investigative Site 114
      • Huntsville, Alabama, United States, 35801
        • Ardelyx Investigative Site 103
      • Huntsville, Alabama, United States, 35802
        • Ardelyx Investigative Site 100
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ardelyx Investigative Site 145
      • Phoenix, Arizona, United States, 85018
        • Ardelyx Investigative Site 210
      • Phoenix, Arizona, United States, 85018
        • Ardelyx Investigative Site 296
      • Tempe, Arizona, United States, 85283
        • Ardelyx Investigative Site 277
      • Tucson, Arizona, United States, 85704
        • Ardelyx Investigative Site 269
      • Tucson, Arizona, United States, 85712
        • Ardelyx Investigative Site 187
      • Tucson, Arizona, United States, 85741
        • Ardelyx Investigative Site 199
    • Arkansas
      • Harrisburg, Arkansas, United States, 72432
        • Ardelyx Investigative Site 140
      • Little Rock, Arkansas, United States, 72209
        • Ardelyx Investigative Site 274
      • Little Rock, Arkansas, United States, 72211
        • Ardelyx Investigative Site 161
      • Little Rock, Arkansas, United States, 72212
        • Ardelyx Investigative Site 122
      • North Little Rock, Arkansas, United States, 72117
        • Ardelyx Investigative Site 129
    • California
      • 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 146
      • Encino, California, United States, 91436
        • Ardelyx Investigative Site 147
      • Lomita, California, United States, 90717
        • Ardelyx Investigative Site 107
      • North Hollywood, California, United States, 91606
        • Ardelyx Investigative Site 112
      • Northridge, California, United States, 91325
        • Ardelyx Investigative Site 110
      • San Diego, California, United States, 92123
        • Ardelyx Investigative Site 294
      • Thousand Oaks, California, United States, 91360
        • Ardelyx Investigative Site 108
    • Florida
      • Cutler Bay, Florida, United States, 33157
        • Ardelyx Investigative Site 178
      • Fort Lauderdale, Florida, United States, 33308
        • Ardelyx Investigative Site 131
      • Hialeah, Florida, United States, 33012
        • Ardelyx Investigative Site 136
      • Hialeah, Florida, United States, 33016
        • Ardelyx Investigative Site 130
      • Homestead, Florida, United States, 33030
        • Ardelyx Investigative Site 287
      • Miami, Florida, United States, 33186
        • Ardelyx Investigative Site 106
      • Miami Lakes, Florida, United States, 33014
        • Ardelyx Investigative Site 127
      • Miami Springs, Florida, United States, 33166
        • Ardelyx Investigative Site 123
      • Pompano Beach, Florida, United States, 33060
        • Ardelyx Investigative Site 126
      • Port Orange, Florida, United States, 32129
        • Ardelyx Investigative Site 132
      • Saint Petersburg, Florida, United States, 33709
        • Ardelyx Investigative Site 150
      • West Palm Beach, Florida, United States, 33409
        • Ardelyx Investigative Site 254
    • Georgia
      • Athens, Georgia, United States, 30607
        • Ardelyx Investigative Site 234
      • Atlanta, Georgia, United States, 30312
        • Ardelyx Investigative Site 138
      • Atlanta, Georgia, United States, 30342
        • Ardelyx Investigative Site 148
      • 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
    • Idaho
      • Boise, Idaho, United States, 83642
        • Ardelyx Investigative Site 157
    • Illinois
      • Blue Island, Illinois, United States, 60406
        • Ardelyx Investigative Site 102
      • Evanston, Illinois, United States, 60201
        • Ardelyx Investigative Site 162
      • Oak Lawn, Illinois, United States, 60453
        • Ardelyx Investigative Site 202
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Ardelyx Investigative Site 259
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Ardelyx Investigative Site 192
      • Metairie, Louisiana, United States, 70006
        • Ardelyx Investigative Site 188
      • Monroe, Louisiana, United States, 71201
        • Ardelyx Investigative Site 177
      • Zachary, Louisiana, United States, 70791
        • Ardelyx Investigative Site 198
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Ardelyx Investigative Site 278
      • Towson, Maryland, United States, 21204
        • Ardelyx Investigative Site 255
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Ardelyx Investigative Site 135
      • Brockton, Massachusetts, United States, 02302
        • Ardelyx Investigative Site 267
    • Michigan
      • Caro, Michigan, United States, 48723
        • Ardelyx Investigative Site 119
      • Chesterfield, Michigan, United States, 48047
        • Ardelyx Investigative Site 128
      • Saginaw, Michigan, United States, 48604
        • Ardelyx Investigative Site 224
    • Missouri
      • Belton, Missouri, United States, 64012
        • Ardelyx Investigative Site 125
    • Montana
      • Billings, Montana, United States, 59102
        • Ardelyx Investigative Site 156
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Ardelyx Investigative Site 142
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • Ardelyx Investigative Site 275
      • Las Vegas, Nevada, United States, 89119
        • Ardelyx Investigative Site 276
      • 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, 87108
        • Ardelyx Investigative Site 293
    • New York
      • Brooklyn, New York, United States, 11215
        • Ardelyx Investigative Site 151
      • Great Neck, New York, United States, 11023
        • Ardelyx Investigative Site 170
      • Hartsdale, New York, United States, 10530
        • Ardelyx Investigative Site 225
      • New Windsor, New York, United States, 12553
        • Ardelyx Investigative Site 206
      • New York, New York, United States, 10036
        • Ardelyx Investigative Site 183
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Ardelyx Investigative Site 226
      • Charlotte, North Carolina, United States, 28210
        • Ardelyx Investigative Site 166
      • Fayetteville, North Carolina, United States, 28304
        • Ardelyx Investigative Site 205
      • Greensboro, North Carolina, United States, 27403
        • Ardelyx Investigative Site 104
      • Kinston, North Carolina, United States, 28501
        • Ardelyx Investigative Site 174
      • Winston-Salem, North Carolina, United States, 27103
        • Ardelyx Investigative Site 280
    • Ohio
      • Beavercreek, Ohio, United States, 45432
        • Ardelyx Investigative Site 172
      • Cincinnati, Ohio, United States, 45219
        • Ardelyx Investigative Site 223
      • Cincinnati, Ohio, United States, 45234
        • Ardelyx Investigative Site 201
      • Columbus, Ohio, United States, 43214
        • Ardelyx Investigative Site 139
      • Dayton, Ohio, United States, 45429
        • Ardelyx Investigative Site 173
      • Huber Heights, Ohio, United States, 45424
        • Ardelyx Investigative Site 171
      • Mentor, Ohio, United States, 44060
        • Ardelyx Investigative Site 117
      • Springfield, Ohio, United States, 45504
        • Ardelyx Investigative Site 247
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Ardelyx Investigative Site 144
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Ardelyx Investigative Site 289
      • Myrtle Beach, South Carolina, United States, 29588
        • Ardelyx Investigative Site 184
      • North Charleston, South Carolina, United States, 29406
        • Ardelyx Investigative Site 281
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Ardelyx Investigative Site 261
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Ardelyx Investigative Site 134
      • 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
      • Nashville, Tennessee, United States, 37211
        • Ardelyx Investigative Site 235
    • Texas
      • Corpus Christi, Texas, United States, 78413
        • Ardelyx Investigative Site 164
      • Corsicana, Texas, United States, 75110
        • Ardelyx Investigative Site 197
      • Houston, Texas, United States, 77079
        • Ardelyx Investigative Site 185
      • Houston, Texas, United States, 77090
        • Ardelyx Investigative Site 120
      • McKinney, Texas, United States, 75071
        • Ardelyx Investigative Site 113
      • Plano, Texas, United States, 75093
        • Ardelyx Investigative Site 111
      • Plano, Texas, United States, 75093
        • Ardelyx Investigative Site 118
      • San Antonio, Texas, United States, 78215
        • Ardelyx Investigative Site 101
      • San Antonio, Texas, United States, 78229
        • Ardelyx Investigative Site 240
    • Utah
      • Orem, Utah, United States, 84058
        • Ardelyx Investigative Site 159
      • Sandy, Utah, United States, 84094
        • Ardelyx Investigative Site 207
      • South Ogden, Utah, United States, 84405
        • Ardelyx Investigative Site 155
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Ardelyx Investigative Site 231
      • Richmond, Virginia, United States, 23294
        • Ardelyx Investigative Site 141

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:

  • 18 to 75 years old
  • 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 an appropriate method 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, or the occurrence of any warning signs

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, ischemic colitis or carcinoid syndrome.
  • Subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician)
  • Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/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 or 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
Drug: Tenapanor
Other Names:
  • RDX5791
  • AZD1722

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 of 12 Week Overall Responder Rate
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate
Time Frame: 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?"
12 weeks
6 of 12 Week Overall Abdominal Pain Responder Rate
Time Frame: 12 weeks
An overall abdominal pain responder is defined as a weekly responder for the first 6/12. 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.
12 weeks
9 of 12 Week Overall Responder Rate
Time Frame: 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.
12 weeks
9 of 12 Week Overall CSBM Responder Rate
Time Frame: 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?"
12 weeks
9 of 12 Week Overall Abdominal Pain Responder Rate
Time Frame: 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.
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

October 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 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-01-301

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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