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

Primary Purpose

Constipation Predominant Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tenapanor
Placebo
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:

  • 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)

Sites / Locations

  • Ardelyx Investigative Site 257
  • Ardelyx Investigative Site 200
  • Ardelyx Investigative Site 103
  • Ardelyx Investigative Site 244
  • Ardelyx Investigative Site 251
  • Ardelyx Investigative Site 100
  • Ardelyx Investigative Site 209
  • Ardelyx Investigative Site 210
  • Ardelyx Investigative Site 296
  • Ardelyx Investigative Site 269
  • Ardelyx Investigative Site 256
  • Ardelyx Investigative Site 292
  • Ardelyx Investigative Site 122
  • Ardelyx Investigative Site 163
  • Ardelyx Investigative Site 105
  • Ardelyx Investigative Site 143
  • Ardelyx Investigative Site 147
  • Ardelyx Investigative Site 297
  • Ardelyx Investigative Site 284
  • Ardelyx Investigative Site 107
  • Ardelyx Investigative Site 165
  • Ardelyx Investigative Site 211
  • Ardelyx Investigative Site 233
  • Ardelyx Investigative Site 212
  • Ardelyx Investigative Site 176
  • Ardelyx Investigative Site 178
  • Ardelyx Investigative Site 136
  • Ardelyx Investigative Site 130
  • Ardelyx Investigative Site 191
  • Ardelyx Investigative Site 127
  • Ardelyx Investigative Site 288
  • Ardelyx Investigative Site 106
  • Ardelyx Investigative Site 179
  • Ardelyx Investigative Site 290
  • Ardelyx Investigative Site 254
  • Ardelyx Investigative Site 138
  • Ardelyx Investigative Site 148
  • Ardelyx Investigative Site 253
  • Ardelyx Investigative Site 272
  • Ardelyx Investigative Site 229
  • Ardelyx Investigative Site 250
  • Ardelyx Investigative Site 137
  • Ardelyx Investigative Site 213
  • Ardelyx Investigative Site 124
  • Ardelyx Investigative Site 268
  • Ardelyx Investigative Site 227
  • Ardelyx Investigative Site 291
  • Ardelyx Investigative Site 202
  • Ardelyx Investigative Site 218
  • Ardelyx Investigative Site 158
  • Ardelyx Investigative Site 270
  • Ardelyx Investigative Site 214
  • Ardelyx Investigative Site 154
  • Ardelyx Investigative Site 195
  • Ardelyx Investigative Site 271
  • Ardelyx Investigative Site 160
  • Ardelyx Investigative Site 255
  • Ardelyx Investigative Site 267
  • Ardelyx Investigative Site 260
  • Ardelyx Investigative Site 283
  • Ardelyx Investigative Site 239
  • Ardelyx Investigative Site 168
  • Ardelyx Investigative Site 216
  • Ardelyx Investigative Site 221
  • Ardelyx Investigative Site 282
  • Ardelyx Investigative Site 228
  • Ardelyx Investigative Site 156
  • Ardelyx Investigative Site 182
  • Ardelyx Investigative Site 175
  • Ardelyx Investigative Site 222
  • Ardelyx Investigative Site 264
  • Ardelyx Investigative Site 230
  • Ardelyx Investigative Site 170
  • Ardelyx Investigative Site 203
  • Ardelyx Investigative Site 205
  • Ardelyx Investigative Site 190
  • Ardelyx Investigative Site 194
  • Ardelyx Investigative Site 285
  • Ardelyx Investigative Site 172
  • Ardelyx Investigative Site 204
  • Ardelyx Investigative Site 201
  • Ardelyx Investigative Site 173
  • Ardelyx Investigative Site 208
  • Ardelyx Investigative Site 171
  • Ardelyx Investigative Site 219
  • Ardelyx Investigative Site 232
  • Ardelyx Investigative Site 236
  • Ardelyx Investigative Site 273
  • Ardelyx Investigative Site 220
  • Ardelyx Investigative Site 248
  • Ardelyx Investigative Site 252
  • Ardelyx Investigative Site 265
  • Ardelyx Investigative Site 246
  • Ardelyx Investigative Site 261
  • Ardelyx Investigative Site 217
  • Ardelyx Investigative Site 121
  • Ardelyx Investigative Site 189
  • Ardelyx Investigative Site 133
  • Ardelyx Investigative Site 109
  • Ardelyx Investigative Site 266
  • Ardelyx Investigative Site 235
  • Ardelyx Investigative Site 279
  • Ardelyx Investigative Site 180
  • Ardelyx Investigative Site 286
  • Ardelyx Investigative Site 262
  • Ardelyx Investigative Site 185
  • Ardelyx Investigative Site 113
  • Ardelyx Investigative Site 263
  • Ardelyx Investigative Site 181
  • Ardelyx Investigative Site 186
  • Ardelyx Investigative Site 167
  • Ardelyx Investigative Site 249
  • Ardelyx Investigative Site 231
  • Ardelyx Investigative Site 258
  • Ardelyx Investigative Site 245
  • Ardelyx Investigative Site 242
  • Ardelyx Investigative Site 195

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

50mg BID

Placebo

Arm Description

Tenapanor, 50mg BID (100mg total)

Placebo

Outcomes

Primary Outcome Measures

Percentage of Subjects With Overall Response for 6 Out of 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.

Secondary Outcome Measures

Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 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?"
Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 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.
Percentage of Subjects With Overall Response for 13 Out of 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.
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 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?"
Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 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.
Percentage of Subjects With Overall Response for 9 Out of 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.
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 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?"
Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 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.

Full Information

First Posted
January 11, 2016
Last Updated
April 10, 2020
Sponsor
Ardelyx
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1. Study Identification

Unique Protocol Identification Number
NCT02686138
Brief Title
A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
Acronym
T3MPO-2
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (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 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.
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.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
593 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50mg BID
Arm Type
Experimental
Arm Description
Tenapanor, 50mg BID (100mg total)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tenapanor
Other Intervention Name(s)
RDX5791, AZD1722
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Subjects With Overall Response for 6 Out of 12 Weeks
Description
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.
Time Frame
First 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks
Description
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?"
Time Frame
First 12 weeks
Title
Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks
Description
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.
Time Frame
First 12 weeks
Title
Percentage of Subjects With Overall Response for 13 Out of 26 Weeks
Description
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.
Time Frame
26 weeks
Title
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks
Description
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?"
Time Frame
26 weeks
Title
Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks
Description
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.
Time Frame
26 weeks
Title
Percentage of Subjects With Overall Response for 9 Out of 12 Weeks
Description
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.
Time Frame
First 12 weeks
Title
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks
Description
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?"
Time Frame
First 12 weeks
Title
Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks
Description
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.
Time Frame
First 12 weeks

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33337659
Citation
Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.
Results Reference
derived

Learn more about this trial

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

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