Trial Outcomes & Findings for A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (NCT NCT02686138)

NCT ID: NCT02686138

Last Updated: 2020-04-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 593 participants
• Primary outcome timeframe: First 12 weeks
• Results posted on: 2020-04-22

Participant Flow

Participant milestones

Measure	50mg BID Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo Placebo Placebo
Overall Study STARTED	293	300
Overall Study COMPLETED	219	235
Overall Study NOT COMPLETED	74	65

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo	Total n=593 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 13.1 • n=5 Participants	44.8 years STANDARD_DEVIATION 13.8 • n=7 Participants	45.4 years STANDARD_DEVIATION 13.46 • n=5 Participants
Sex: Female, Male Female	240 Participants n=5 Participants	247 Participants n=7 Participants	487 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=5 Participants	78 Participants n=7 Participants	155 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	216 Participants n=5 Participants	222 Participants n=7 Participants	438 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	92 Participants n=5 Participants	92 Participants n=7 Participants	184 Participants n=5 Participants
Race (NIH/OMB) White	185 Participants n=5 Participants	192 Participants n=7 Participants	377 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Body Mass Index (BMI)	30.50 kg/m^2 STANDARD_DEVIATION 7.18 • n=5 Participants	30.88 kg/m^2 STANDARD_DEVIATION 7.27 • n=7 Participants	30.69 kg/m^2 STANDARD_DEVIATION 7.22 • n=5 Participants

PRIMARY outcome

Timeframe: First 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.

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Response for 6 Out of 12 Weeks	107 Participants	71 Participants

SECONDARY outcome

Timeframe: First 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?"

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks	139 Participants	100 Participants

SECONDARY outcome

Timeframe: First 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.

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks	146 Participants	115 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Response for 13 Out of 26 Weeks	104 Participants	73 Participants

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks	121 Participants	93 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks	147 Participants	120 Participants

SECONDARY outcome

Timeframe: First 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.

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Response for 9 Out of 12 Weeks	54 Participants	16 Participants

SECONDARY outcome

Timeframe: First 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?"

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks	65 Participants	18 Participants

SECONDARY outcome

Timeframe: First 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.

Outcome measures

Measure	50mg BID n=293 Participants Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 Participants Placebo Placebo
Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks	105 Participants	80 Participants

Adverse Events

50mg BID

Serious events: 4 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	50mg BID n=293 participants at risk Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 participants at risk Placebo Placebo
Gastrointestinal disorders Abdominal Pain	0.34% 1/293 • Number of events 1 • 6 months	0.00% 0/300 • 6 months
Respiratory, thoracic and mediastinal disorders COPD	0.34% 1/293 • Number of events 1 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Gastrointestinal disorders Diarrhea	0.34% 1/293 • Number of events 1 • 6 months	0.00% 0/300 • 6 months
Gastrointestinal disorders Nausea	0.34% 1/293 • Number of events 1 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Infections and infestations Bacterial Infection	0.00% 0/293 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Cardiac disorders carotid artery occlusion	0.00% 0/293 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Vascular disorders ovarian vein thrombosis	0.00% 0/293 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/293 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Renal and urinary disorders pyelonephritis	0.00% 0/293 • 6 months	0.33% 1/300 • Number of events 1 • 6 months
Immune system disorders systemic inflammatory response syndrome	0.00% 0/293 • 6 months	0.33% 1/300 • Number of events 1 • 6 months

Other adverse events

Measure	50mg BID n=293 participants at risk Tenapanor, 50mg BID (100mg total) Tenapanor	Placebo n=300 participants at risk Placebo Placebo
Gastrointestinal disorders Diarrhea	16.0% 47/293 • Number of events 47 • 6 months	3.7% 11/300 • Number of events 11 • 6 months

Additional Information

Chief Development Officer

Ardelyx

Phone: 6175134929

Email: drosenbaum@ardelyx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60