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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02686138
Recruitment Status : Completed
First Posted : February 19, 2016
Results First Posted : April 13, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Constipation Predominant Irritable Bowel Syndrome
Interventions Drug: Tenapanor
Drug: Placebo
Enrollment 593
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Period Title: Overall Study
Started 293 300
Completed 219 235
Not Completed 74 65
Arm/Group Title 50mg BID Placebo Total
Hide Arm/Group Description

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo

 Total of all reporting groups
Overall Number of Baseline Participants 293 300 593
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 293 participants 300 participants 593 participants
46.1  (13.1) 44.8  (13.8) 45.4  (13.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 300 participants 593 participants
Female
240
  81.9%
247
  82.3%
487
  82.1%
Male
53
  18.1%
53
  17.7%
106
  17.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 300 participants 593 participants
Hispanic or Latino
77
  26.3%
78
  26.0%
155
  26.1%
Not Hispanic or Latino
216
  73.7%
222
  74.0%
438
  73.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 300 participants 593 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.2%
Asian
12
   4.1%
9
   3.0%
21
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
92
  31.4%
92
  30.7%
184
  31.0%
White
185
  63.1%
192
  64.0%
377
  63.6%
More than one race
1
   0.3%
3
   1.0%
4
   0.7%
Unknown or Not Reported
2
   0.7%
4
   1.3%
6
   1.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 293 participants 300 participants 593 participants
30.50  (7.18) 30.88  (7.27) 30.69  (7.22)
1.Primary Outcome
Title Percentage of Subjects With Overall Response for 6 Out of 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
107
  36.5%
71
  23.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.85
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
139
  47.4%
100
  33.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 14.11
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
146
  49.8%
115
  38.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects With Overall Response for 13 Out of 26 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
104
  35.5%
73
  24.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.16
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
121
  41.3%
93
  31.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
147
  50.2%
120
  40.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.17
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Subjects With Overall Response for 9 Out of 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
54
  18.4%
16
   5.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
65
  22.2%
18
   6.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.18
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
Overall Number of Participants Analyzed 293 300
Measure Type: Count of Participants
Unit of Measure: Participants
105
  35.8%
80
  26.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.17
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description

Tenapanor, 50mg BID (100mg total)

Tenapanor

Placebo

Placebo
All-Cause Mortality
50mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/293 (0.00%)      0/300 (0.00%)    
Hide Serious Adverse Events
50mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/293 (1.37%)      8/300 (2.67%)    
Cardiac disorders     
carotid artery occlusion †  0/293 (0.00%)  0 1/300 (0.33%)  1
Gastrointestinal disorders     
Abdominal Pain †  1/293 (0.34%)  1 0/300 (0.00%)  0
Diarrhea †  1/293 (0.34%)  1 0/300 (0.00%)  0
Nausea †  1/293 (0.34%)  1 1/300 (0.33%)  1
Immune system disorders     
systemic inflammatory response syndrome †  0/293 (0.00%)  0 1/300 (0.33%)  1
Infections and infestations     
Bacterial Infection †  0/293 (0.00%)  0 1/300 (0.33%)  1
Renal and urinary disorders     
pyelonephritis †  0/293 (0.00%)  0 1/300 (0.33%)  1
Respiratory, thoracic and mediastinal disorders     
COPD †  1/293 (0.34%)  1 1/300 (0.33%)  1
pulmonary embolism †  0/293 (0.00%)  0 1/300 (0.33%)  1
Vascular disorders     
ovarian vein thrombosis †  0/293 (0.00%)  0 1/300 (0.33%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
50mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/293 (16.04%)      11/300 (3.67%)    
Gastrointestinal disorders     
Diarrhea †  47/293 (16.04%)  47 11/300 (3.67%)  11
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Development Officer
Organization: Ardelyx
Phone: 6175134929
EMail: drosenbaum@ardelyx.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02686138    
Other Study ID Numbers: TEN-01-302
First Submitted: January 11, 2016
First Posted: February 19, 2016
Results First Submitted: March 30, 2020
Results First Posted: April 13, 2020
Last Update Posted: April 22, 2020