A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2)
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ClinicalTrials.gov Identifier: NCT02686138 |
Recruitment Status :
Completed
First Posted : February 19, 2016
Results First Posted : April 13, 2020
Last Update Posted : April 22, 2020
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Sponsor:
Ardelyx
Information provided by (Responsible Party):
Ardelyx
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 50mg BID | Placebo |
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Tenapanor, 50mg BID (100mg total) Tenapanor |
Placebo Placebo |
Period Title: Overall Study | ||
Started | 293 | 300 |
Completed | 219 | 235 |
Not Completed | 74 | 65 |
Baseline Characteristics
Arm/Group Title | 50mg BID | Placebo | Total | |
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Tenapanor, 50mg BID (100mg total) Tenapanor |
Placebo Placebo |
Total of all reporting groups | |
Overall Number of Baseline Participants | 293 | 300 | 593 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 293 participants | 300 participants | 593 participants | |
Female |
240 81.9%
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247 82.3%
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487 82.1%
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Male |
53 18.1%
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53 17.7%
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106 17.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 293 participants | 300 participants | 593 participants | |
Hispanic or Latino |
77 26.3%
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78 26.0%
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155 26.1%
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Not Hispanic or Latino |
216 73.7%
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222 74.0%
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438 73.9%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 293 participants | 300 participants | 593 participants | |
American Indian or Alaska Native |
1 0.3%
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0 0.0%
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1 0.2%
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Asian |
12 4.1%
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9 3.0%
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21 3.5%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
92 31.4%
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92 30.7%
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184 31.0%
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White |
185 63.1%
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192 64.0%
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377 63.6%
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More than one race |
1 0.3%
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3 1.0%
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4 0.7%
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Unknown or Not Reported |
2 0.7%
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4 1.3%
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6 1.0%
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Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 293 participants | 300 participants | 593 participants | |
30.50 (7.18) | 30.88 (7.27) | 30.69 (7.22) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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 |