This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.
This study consists of a 2-week Screening period, followed by a 26-week randomized treatment period (RTP), and a 4-week treatment-free Safety Follow-up period. After obtaining study informed consent from patients, the 2-week Screening period starts. Patients will be fully assessed for eligibility into the study. The assessments will include evaluation of inclusion/exclusion criteria, including medical histories, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Patients will also self-report, on information about the status of their constipation symptoms and severity via an electronic diary (eDiary). Patient compliance with the eDiary will be monitored to determine eligibility at the end of screening. Eligible patients will be randomized (Visit 2) to receive tenapanor 5 mg BID (twice a day), 25 mg BID, 50 mg BID, or placebo for 26 consecutive weeks as the double-blind RTP. During this period, patients will continue recording daily assessments of constipation symptoms and weekly assessments of constipation severity in the eDiary. Patients will have return visits every two to six weeks at Weeks 2, 4, 8, 12, 16, 20 and 26(Visit 3-9) to undergo safety assessments. Upon completion of the 26-week RTP, patients will be monitored for AEs (adverse events) during the 4-week treatment-free Safety Follow-up period and complete the Follow-up visit (Visit 10) at the end of this period to undergo safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
692
Patients will receive tenapanor 5 mg BID (total of 10 mg daily)
Patients will receive tenapanor 25 mg BID (total of 50 mg daily)
Patients will receive tenapanor 50 mg BID (total of 100 mg daily)
Durable complete spontaneous bowel movements (CSBM) response
Durable complete spontaneous bowel movements (CSBM) response is defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period and and for ≥3 of the last 4 weeks of the first 12 weeks of randomized treatment period
Time frame: 12 Weeks
9/12 week complete spontaneous bowel movements (CSBM) response
9/12 week complete spontaneous bowel movements (CSBM) response defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period.
Time frame: 12 Weeks
Change from baseline in complete spontaneous bowel movements (CSBM) frequency
Change from baseline over the first 12 weeks of the randomized treatment period in complete spontaneous bowel movements (CSBM) frequency
Time frame: 12 Weeks
Change from baseline in spontaneous bowel movement (SBM) frequency
Change from baseline over the first 12 weeks of the randomized treatment period in spontaneous bowel movement (SBM) frequency
Time frame: 12 Weeks
Change from baseline in stool consistency
Change from baseline over the first 12 weeks of the randomized treatment period in stool consistency
Time frame: 12 Weeks
Change from baseline in stool straining
Change from baseline over the first 12 weeks of the randomized treatment period in straining
Time frame: 12 Weeks
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Patients will receive matching placebo BID
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