Trial Outcomes & Findings for 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 (NCT NCT02621892)

Last Updated: 2020-04-21

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

606 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	50mg BID Tenapanor Tenapanor	Placebo Placebo Placebo
Treatment Period STARTED	307	299
Treatment Period COMPLETED	261	272
Treatment Period NOT COMPLETED	46	27
Randomized Withdrawal Period STARTED	261	272
Randomized Withdrawal Period COMPLETED	250	260
Randomized Withdrawal Period NOT COMPLETED	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo	Total n=606 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 13.38 • n=5 Participants	44.9 years STANDARD_DEVIATION 13.04 • n=7 Participants	45 years STANDARD_DEVIATION 13.20 • n=5 Participants
Sex: Female, Male Female	244 Participants n=5 Participants	249 Participants n=7 Participants	493 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	50 Participants n=7 Participants	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	98 Participants n=5 Participants	83 Participants n=7 Participants	181 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	209 Participants n=5 Participants	216 Participants n=7 Participants	425 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	4 Participants n=7 Participants	14 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	88 Participants n=5 Participants	100 Participants n=7 Participants	188 Participants n=5 Participants
Race (NIH/OMB) White	201 Participants n=5 Participants	186 Participants n=7 Participants	387 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	29.88 kg/m^2 STANDARD_DEVIATION 7.198 • n=5 Participants	29.30 kg/m^2 STANDARD_DEVIATION 6.442 • n=7 Participants	29.60 kg/m^2 STANDARD_DEVIATION 6.836 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo
6 of 12 Week Overall Responder Rate	83 Participants	56 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo
6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate	104 Participants	88 Participants

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo
6 of 12 Week Overall Abdominal Pain Responder Rate	135 Participants	99 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo
9 of 12 Week Overall Responder Rate	42 Participants	10 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo
9 of 12 Week Overall CSBM Responder Rate	52 Participants	15 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures
Measure	50mg BID n=307 Participants Tenapanor Tenapanor	Placebo n=299 Participants Placebo Placebo
9 of 12 Week Overall Abdominal Pain Responder Rate	93 Participants	58 Participants

Adverse Events

50mg BID

Serious events: 6 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	50mg BID n=307 participants at risk Tenapanor Tenapanor	Placebo n=299 participants at risk Placebo Placebo
Musculoskeletal and connective tissue disorders Osteoarthritis	0.33% 1/307 • Number of events 1 • 4 months	0.00% 0/299 • 4 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pineal neoplasm	0.33% 1/307 • Number of events 1 • 4 months	0.00% 0/299 • 4 months
Nervous system disorders Migraine	0.33% 1/307 • Number of events 1 • 4 months	0.00% 0/299 • 4 months
Psychiatric disorders Panick Attack	0.33% 1/307 • Number of events 1 • 4 months	0.00% 0/299 • 4 months
Psychiatric disorders Alcohol withdrawal syndromw	0.33% 1/307 • Number of events 1 • 4 months	0.00% 0/299 • 4 months
Psychiatric disorders Major Depression	0.33% 1/307 • Number of events 1 • 4 months	0.00% 0/299 • 4 months

Other adverse events

Other adverse events
Measure	50mg BID n=307 participants at risk Tenapanor Tenapanor	Placebo n=299 participants at risk Placebo Placebo
Gastrointestinal disorders Diarrhea	14.7% 45/307 • Number of events 45 • 4 months	1.7% 5/299 • Number of events 5 • 4 months

Additional Information

Chief Development Officer

Ardelyx

Phone: 6175134929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60