This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and \<18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP) and a 2-week treatment-free Follow-Up period (only for patients who will not enter the 40-week Long Term Safety Extension Study \[TEN-01-306\]). At the beginning of the 2-week Screening period, patients who provide written assent will be fully assessed for eligibility into the study and will be asked to self-report daily information about the status of their IBS symptoms via an electronic diary (eDiary) device. Patient compliance with the eDiary will be monitored actively by the site staff and will be reviewed to determine eligibility at the end of screening. Eligible patients will be randomized to receive one of the study medications: tenapanor 25 mg BID, tenapanor 50 mg BID, or placebo. During the 12-week double-blind RTP, patients will continue recording daily assessments via the eDiary system as instructed and compliance with eDiary entries will be monitored on an ongoing basis. Patients will return for study visit every two or four weeks (Visits 3-6) and will undergo safety assessments at these visits. Patients who do not enter the 40-week Long Term Safety Extension Study \[TEN-01-306\] including those who complete the RTP but do not enter study TEN-01-306 and those who prematurely discontinue from the RTP, a Follow-Up Visit will be scheduled approximately 2 weeks after the completion of the RTP (Visit 6) or the Early Termination Visit at which safety assessments will be performed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Participants will receive tenapanor 50 mg BID (total of 100 mg daily)
Participants will receive tenapanor 25 mg BID (total of 50 mg daily)
Participants will be randomized to receive matching placebo
6/12-week APS (abdominal pain and SBM) +2 response
6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP. * The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week * The weekly abdominal pain response is defined as having ≥30% reduction from baseline in the average weekly abdominal pain score for a given week
Time frame: 12 weeks
6/12-week SBM +2 response
6/12-week SBM +2 response: defined as achieving the weekly SBM +2 response for ≥6 out of the 12 weeks of the RTP
Time frame: 12 weeks
6/12-week abdominal pain response
6/12-week abdominal pain response: defined as achieving the weekly abdominal pain response for ≥6 out of the 12 weeks of the RTP
Time frame: 12 weeks
Change from baseline in average weekly SBM frequency
Change from baseline in average weekly SBM frequency
Time frame: 12 weeks
Change from baseline in average weekly stool consistency score
Change from baseline in average weekly stool consistency score
Time frame: 12 weeks
Change from baseline in average weekly abdominal pain score
Change from baseline in average weekly abdominal pain score
Time frame: 12 weeks
Overall use of rescue medication
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G & L Research, LLC
Foley, Alabama, United States
COMPLETEDEclipse Clinical Research
Tucson, Arizona, United States
RECRUITINGAdvanced Research Center, Inc.
Anaheim, California, United States
RECRUITINGConnecticut Children's Medical Center
Hartford, Connecticut, United States
RECRUITINGProhealth Research Center
Doral, Florida, United States
RECRUITINGI.H.S. Health, LLC
Kissimmee, Florida, United States
TERMINATEDWaterway Research & Associates Corp
Miami, Florida, United States
RECRUITINGValencia Medical and Research Center
Miami, Florida, United States
RECRUITINGOrlando Health, Inc.- APH Center for Digestive Health and Nutrition
Orlando, Florida, United States
RECRUITINGFlorida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, United States
RECRUITING...and 31 more locations
Overall use of rescue medication
Time frame: 12 weeks