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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)

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ClinicalTrials.gov Identifier: NCT02621892
Recruitment Status : Completed
First Posted : December 4, 2015
Results First Posted : April 21, 2020
Last Update Posted : April 21, 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 606
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description

Tenapanor

Tenapanor

Placebo

Placebo

Period Title: Treatment Period
Started 307 299
Completed 261 272
Not Completed 46 27
Period Title: Randomized Withdrawal Period
Started 261 272
Completed 250 260
Not Completed 11 12
Arm/Group Title 50mg BID Placebo Total
Hide Arm/Group Description

Tenapanor

Tenapanor

Placebo

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 307 299 606
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 307 participants 299 participants 606 participants
45  (13.38) 44.9  (13.04) 45  (13.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants 299 participants 606 participants
Female
244
  79.5%
249
  83.3%
493
  81.4%
Male
63
  20.5%
50
  16.7%
113
  18.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants 299 participants 606 participants
Hispanic or Latino
98
  31.9%
83
  27.8%
181
  29.9%
Not Hispanic or Latino
209
  68.1%
216
  72.2%
425
  70.1%
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 307 participants 299 participants 606 participants
American Indian or Alaska Native
0
   0.0%
2
   0.7%
2
   0.3%
Asian
10
   3.3%
4
   1.3%
14
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
88
  28.7%
100
  33.4%
188
  31.0%
White
201
  65.5%
186
  62.2%
387
  63.9%
More than one race
8
   2.6%
7
   2.3%
15
   2.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 307 participants 299 participants 606 participants
29.88  (7.198) 29.30  (6.442) 29.60  (6.836)
1.Primary Outcome
Title 6 of 12 Week Overall Responder Rate
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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor

Tenapanor

Placebo

Placebo

Overall Number of Participants Analyzed 307 299
Measure Type: Count of Participants
Unit of Measure: Participants
83
  27.0%
56
  18.7%
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 <0.02
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.31
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate
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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor

Tenapanor

Placebo

Placebo

Overall Number of Participants Analyzed 307 299
Measure Type: Count of Participants
Unit of Measure: Participants
104
  33.9%
88
  29.4%
3.Secondary Outcome
Title 6 of 12 Week Overall Abdominal Pain Responder Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor

Tenapanor

Placebo

Placebo

Overall Number of Participants Analyzed 307 299
Measure Type: Count of Participants
Unit of Measure: Participants
135
  44.0%
99
  33.1%
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 <0.008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.86
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 9 of 12 Week Overall Responder Rate
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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor

Tenapanor

Placebo

Placebo

Overall Number of Participants Analyzed 307 299
Measure Type: Count of Participants
Unit of Measure: Participants
42
  13.7%
10
   3.3%
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 10.34
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 9 of 12 Week Overall CSBM Responder Rate
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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor

Tenapanor

Placebo

Placebo

Overall Number of Participants Analyzed 307 299
Measure Type: Count of Participants
Unit of Measure: Participants
52
  16.9%
15
   5.0%
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 11.92
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 9 of 12 Week Overall Abdominal Pain Responder Rate
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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description:

Tenapanor

Tenapanor

Placebo

Placebo

Overall Number of Participants Analyzed 307 299
Measure Type: Count of Participants
Unit of Measure: Participants
93
  30.3%
58
  19.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50mg BID
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 10.9
Estimation Comments [Not Specified]
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 50mg BID Placebo
Hide Arm/Group Description

Tenapanor

Tenapanor

Placebo

Placebo

All-Cause Mortality
50mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/307 (0.00%)      0/299 (0.00%)    
Hide Serious Adverse Events
50mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/307 (1.95%)      0/299 (0.00%)    
Musculoskeletal and connective tissue disorders     
Osteoarthritis   1/307 (0.33%)  1 0/299 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pineal neoplasm   1/307 (0.33%)  1 0/299 (0.00%)  0
Nervous system disorders     
Migraine   1/307 (0.33%)  1 0/299 (0.00%)  0
Psychiatric disorders     
Panick Attack   1/307 (0.33%)  1 0/299 (0.00%)  0
Alcohol withdrawal syndromw   1/307 (0.33%)  1 0/299 (0.00%)  0
Major Depression   1/307 (0.33%)  1 0/299 (0.00%)  0
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   45/307 (14.66%)      5/299 (1.67%)    
Gastrointestinal disorders     
Diarrhea   45/307 (14.66%)  45 5/299 (1.67%)  5
Indicates events were collected by systematic assessment
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
Layout table for additonal information
Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02621892    
Other Study ID Numbers: TEN-01-301
First Submitted: December 2, 2015
First Posted: December 4, 2015
Results First Submitted: March 30, 2020
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020