Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study. Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
150
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Safety Measure Assessment (Adverse Event)
Incidence of AEs, SAEs and drug related adverse events
Time frame: 40 weeks
Safety Measure Assessment (ECG)
Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)
Time frame: 40 weeks
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G & L Research, LLC
Foley, Alabama, United States
Advanced Research Center, Inc.
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I.H.S. Health, LLC
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Valencia Medical and Research Center
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Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
Orlando, Florida, United States
Florida Pharmaceutical Research and Associates, Inc.
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OSF Saint Francis Medical Center
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Riley Children's Health
Indianapolis, Indiana, United States
Maine Health
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...and 17 more locations