A 26-Week Study to Evaluate the Efficacy and Safety of Te... | NCT02686138

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
50mg BID	Experimental	Tenapanor, 50mg BID (100mg total)	Drug: Tenapanor
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tenapanor	Drug		50mg BID	RDX5791 AZD1722
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Overall Response for 6 Out of 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.	First 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 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?"

Eligibility Module

Name	Affiliation	Role
David P Rosenbaum, Ph.D.	Ardelyx, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Ardelyx Investigative Site 257		Dothan	Alabama	36305	United States
Ardelyx Investigative Site 200

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41601848	Derived	Lacy BE, Shin AS, Cangemi DJ, Yang Y, Zhao S, Rosenbaum DP. Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis. Ther Adv Gastroenterol. 2026 Jan 24;19:17562848251414831. doi: 10.1177/17562848251414831. eCollection 2026.
37668173	Derived	Lembo AJ, Friedenberg KA, Fogel RP, Edelstein S, Zhao S, Yang Y, Rosenbaum DP, Chey WD. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023 Nov;35(11):e14658. doi: 10.1111/nmo.14658. Epub 2023 Sep 5.

Results Section

Participant Flow Module

ID	Title	Description
FG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
FG001	Placebo	Placebo Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 6, 2015	Mar 30, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.1± 13.1 BG00144.8± 13.8 BG00245.4± 13.46

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000240 BG001247 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00077 BG00178 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00030.50± 7.18 BG00130.88± 7.27 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With Overall Response for 6 Out of 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.

Posted

Count of Participants

Participants

First 12 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000293 OG001300

Title

Denominators

Categories

Title	Measurements
	OG000107 OG00171

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<0.001		Risk Difference (RD)	12.85			2-Sided								Superiority

Secondary

Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 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?"

Posted

Count of Participants

Participants

First 12 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 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.

Posted

Count of Participants

Participants

First 12 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Response for 13 Out of 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.

Posted

Count of Participants

Participants

26 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 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?"

Posted

Count of Participants

Participants

26 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 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.

Posted

Count of Participants

Participants

26 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Response for 9 Out of 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.

Posted

Count of Participants

Participants

First 12 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 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?"

Posted

Count of Participants

Participants

First 12 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 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.

Posted

Count of Participants

Participants

First 12 weeks

ID	Title	Description
OG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
OG001	Placebo	Placebo Placebo

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor	0	293	4	293	47	293
EG001	Placebo	Placebo Placebo	0	300	8	300	11	300

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected293 at risk EG0010 events0 affected300 at risk
COPD	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected293 at risk EG0011 events1 affected300 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected293 at risk EG0010 events0 affected300 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected293 at risk EG0011 events1 affected300 at risk
Bacterial Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected293 at risk EG0011 events1 affected300 at risk
carotid artery occlusion	Cardiac disorders	Systematic Assessment	EG0000 events0 affected293 at risk EG0011 events1 affected300 at risk
ovarian vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected293 at risk EG0011 events1 affected300 at risk
pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected293 at risk EG0011 events1 affected300 at risk
pyelonephritis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected293 at risk EG0011 events1 affected300 at risk
systemic inflammatory response syndrome	Immune system disorders	Systematic Assessment	EG0000 events0 affected293 at risk EG0011 events1 affected300 at risk

ID	Title	Description
BG000	50mg BID	Tenapanor, 50mg BID (100mg total) Tenapanor
BG001	Placebo	Placebo Placebo
BG002	Total	Total of all reporting groups