Trial Outcomes & Findings for A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C (NCT NCT02727751)

Last Updated: 2020-09-09

Results Overview

Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

312 participants

Primary outcome timeframe

52-55 weeks

Results posted on

2020-09-09

Participant milestones
Measure	50mg BID Tenapanor, 50 mg BID (100 mg total)
Overall Study STARTED	312
Overall Study COMPLETED	262
Overall Study NOT COMPLETED	50

Withdrawal data not reported

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Baseline characteristics by cohort
Measure	50mg BID n=312 Participants Tenapanor, 50 mg BID (100 mg total)
Age, Continuous	49.5 years STANDARD_DEVIATION 13.15 • n=5 Participants
Sex: Female, Male Female	255 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	182 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	89 Participants n=5 Participants
Race (NIH/OMB) White	217 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Body Mass Index (BMI)	29.98 kg/m^2 STANDARD_DEVIATION 6.707 • n=5 Participants

Timeframe: 52-55 weeks

Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams

Outcome measures
Measure	50mg BID n=312 Participants Tenapanor, 50 mg BID (100 mg total)
Adverse Events in >2% Patients Diarrhea	33 participants
Adverse Events in >2% Patients Flatulence	7 participants
Adverse Events in >2% Patients Upper Respiratory Tract Infection	7 participants
Adverse Events in >2% Patients Headache	11 participants

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events
Measure	50mg BID n=312 participants at risk Tenapanor, 50 mg BID (100 mg total)
Blood and lymphatic system disorders Leukocytosis	0.32% 1/312 • Number of events 1 • This was an extension study that ran for up to 1 year
Injury, poisoning and procedural complications Rib Fracture	0.32% 1/312 • Number of events 1 • This was an extension study that ran for up to 1 year
Reproductive system and breast disorders Endometriosis	0.32% 1/312 • Number of events 1 • This was an extension study that ran for up to 1 year

Other adverse events
Measure	50mg BID n=312 participants at risk Tenapanor, 50 mg BID (100 mg total)
Gastrointestinal disorders Diarrhea	10.6% 33/312 • Number of events 33 • This was an extension study that ran for up to 1 year

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