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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)

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:

  • 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)

Sites / Locations

  • Ardelyx Investigative Site 149
  • Ardelyx Investigative Site 114
  • Ardelyx Investigative Site 103
  • Ardelyx Investigative Site 100
  • Ardelyx Investigative Site 145
  • Ardelyx Investigative Site 210
  • Ardelyx Investigative Site 296
  • Ardelyx Investigative Site 277
  • Ardelyx Investigative Site 269
  • Ardelyx Investigative Site 187
  • Ardelyx Investigative Site 199
  • Ardelyx Investigative Site 140
  • Ardelyx Investigative Site 274
  • Ardelyx Investigative Site 161
  • Ardelyx Investigative Site 122
  • Ardelyx Investigative Site 129
  • Ardelyx Investigative Site 105
  • Ardelyx Investigative Site 143
  • Ardelyx Investigative Site 146
  • Ardelyx Investigative Site 147
  • Ardelyx Investigative Site 107
  • Ardelyx Investigative Site 112
  • Ardelyx Investigative Site 110
  • Ardelyx Investigative Site 294
  • Ardelyx Investigative Site 108
  • Ardelyx Investigative Site 178
  • Ardelyx Investigative Site 131
  • Ardelyx Investigative Site 136
  • Ardelyx Investigative Site 130
  • Ardelyx Investigative Site 287
  • Ardelyx Investigative Site 127
  • Ardelyx Investigative Site 123
  • Ardelyx Investigative Site 106
  • Ardelyx Investigative Site 126
  • Ardelyx Investigative Site 132
  • Ardelyx Investigative Site 150
  • Ardelyx Investigative Site 254
  • Ardelyx Investigative Site 234
  • Ardelyx Investigative Site 138
  • Ardelyx Investigative Site 148
  • Ardelyx Investigative Site 137
  • Ardelyx Investigative Site 213
  • Ardelyx Investigative Site 124
  • Ardelyx Investigative Site 157
  • Ardelyx Investigative Site 102
  • Ardelyx Investigative Site 162
  • Ardelyx Investigative Site 202
  • Ardelyx Investigative Site 259
  • Ardelyx Investigative Site 192
  • Ardelyx Investigative Site 188
  • Ardelyx Investigative Site 177
  • Ardelyx Investigative Site 198
  • Ardelyx Investigative Site 278
  • Ardelyx Investigative Site 255
  • Ardelyx Investigative Site 135
  • Ardelyx Investigative Site 267
  • Ardelyx Investigative Site 119
  • Ardelyx Investigative Site 128
  • Ardelyx Investigative Site 224
  • Ardelyx Investigative Site 125
  • Ardelyx Investigative Site 156
  • Ardelyx Investigative Site 142
  • Ardelyx Investigative Site 275
  • Ardelyx Investigative Site 276
  • Ardelyx Investigative Site 182
  • Ardelyx Investigative Site 175
  • Ardelyx Investigative Site 293
  • Ardelyx Investigative Site 151
  • Ardelyx Investigative Site 170
  • Ardelyx Investigative Site 225
  • Ardelyx Investigative Site 206
  • Ardelyx Investigative Site 183
  • Ardelyx Investigative Site 226
  • Ardelyx Investigative Site 166
  • Ardelyx Investigative Site 205
  • Ardelyx Investigative Site 104
  • Ardelyx Investigative Site 174
  • Ardelyx Investigative Site 280
  • Ardelyx Investigative Site 172
  • Ardelyx Investigative Site 223
  • Ardelyx Investigative Site 201
  • Ardelyx Investigative Site 139
  • Ardelyx Investigative Site 173
  • Ardelyx Investigative Site 171
  • Ardelyx Investigative Site 117
  • Ardelyx Investigative Site 247
  • Ardelyx Investigative Site 144
  • Ardelyx Investigative Site 289
  • Ardelyx Investigative Site 184
  • Ardelyx Investigative Site 281
  • Ardelyx Investigative Site 261
  • Ardelyx Investigative Site 134
  • Ardelyx Investigative Site 121
  • Ardelyx Investigative Site 189
  • Ardelyx Investigative Site 133
  • Ardelyx Investigative Site 109
  • Ardelyx Investigative Site 235
  • Ardelyx Investigative Site 164
  • Ardelyx Investigative Site 197
  • Ardelyx Investigative Site 185
  • Ardelyx Investigative Site 120
  • Ardelyx Investigative Site 113
  • Ardelyx Investigative Site 111
  • Ardelyx Investigative Site 118
  • Ardelyx Investigative Site 101
  • Ardelyx Investigative Site 240
  • Ardelyx Investigative Site 159
  • Ardelyx Investigative Site 207
  • Ardelyx Investigative Site 155
  • Ardelyx Investigative Site 231
  • Ardelyx Investigative Site 141

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

50mg BID

Placebo

Arm Description

Tenapanor

Placebo

Outcomes

Primary Outcome Measures

6 of 12 Week Overall Responder Rate
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

6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate
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?"
6 of 12 Week Overall Abdominal Pain Responder Rate
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.
9 of 12 Week Overall Responder Rate
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.
9 of 12 Week Overall CSBM Responder Rate
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?"
9 of 12 Week Overall Abdominal Pain Responder Rate
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
December 2, 2015
Last Updated
April 10, 2020
Sponsor
Ardelyx
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1. Study Identification

Unique Protocol Identification Number
NCT02621892
Brief Title
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
Acronym
T3MPO-1
Official Title
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)
Study Type
Interventional

2. Study Status

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

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
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50mg BID
Arm Type
Experimental
Arm Description
Tenapanor
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
6 of 12 Week Overall Responder Rate
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
12 weeks
Secondary Outcome Measure Information:
Title
6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate
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
12 weeks
Title
6 of 12 Week Overall Abdominal Pain Responder Rate
Description
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.
Time Frame
12 weeks
Title
9 of 12 Week Overall Responder Rate
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
12 weeks
Title
9 of 12 Week Overall CSBM Responder Rate
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
12 weeks
Title
9 of 12 Week Overall Abdominal Pain Responder Rate
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
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: 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)
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 149
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Ardelyx Investigative Site 114
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
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 100
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Ardelyx Investigative Site 145
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
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 277
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
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 187
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Ardelyx Investigative Site 199
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Ardelyx Investigative Site 140
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
Ardelyx Investigative Site 274
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Ardelyx Investigative Site 161
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
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 129
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
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 146
City
Encino
State/Province
California
ZIP/Postal Code
91436
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 107
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Ardelyx Investigative Site 112
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Ardelyx Investigative Site 110
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Ardelyx Investigative Site 294
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ardelyx Investigative Site 108
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
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 131
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
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 287
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
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 123
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
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 126
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Ardelyx Investigative Site 132
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Ardelyx Investigative Site 150
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
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 234
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
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 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 157
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Ardelyx Investigative Site 102
City
Blue Island
State/Province
Illinois
ZIP/Postal Code
60406
Country
United States
Facility Name
Ardelyx Investigative Site 162
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
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 259
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Ardelyx Investigative Site 192
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Ardelyx Investigative Site 188
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Ardelyx Investigative Site 177
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Ardelyx Investigative Site 198
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Ardelyx Investigative Site 278
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
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 135
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
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 119
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
Ardelyx Investigative Site 128
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Ardelyx Investigative Site 224
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Ardelyx Investigative Site 125
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
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 142
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Ardelyx Investigative Site 275
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Ardelyx Investigative Site 276
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
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 293
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Ardelyx Investigative Site 151
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
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 225
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Ardelyx Investigative Site 206
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Ardelyx Investigative Site 183
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Ardelyx Investigative Site 226
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Ardelyx Investigative Site 166
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
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 104
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Ardelyx Investigative Site 174
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Ardelyx Investigative Site 280
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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 223
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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 139
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
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 171
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Ardelyx Investigative Site 117
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Ardelyx Investigative Site 247
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Ardelyx Investigative Site 144
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Ardelyx Investigative Site 289
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Ardelyx Investigative Site 184
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
Facility Name
Ardelyx Investigative Site 281
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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 134
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
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 235
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Ardelyx Investigative Site 164
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
Ardelyx Investigative Site 197
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
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 120
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
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 111
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Ardelyx Investigative Site 118
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Ardelyx Investigative Site 101
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Ardelyx Investigative Site 240
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ardelyx Investigative Site 159
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Ardelyx Investigative Site 207
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
Ardelyx Investigative Site 155
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
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 141
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

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
PubMed Identifier
31934897
Citation
Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). Am J Gastroenterol. 2020 Feb;115(2):281-293. doi: 10.14309/ajg.0000000000000516.
Results Reference
derived

Learn more about this trial

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

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