4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
Trial Parameters
Brief Summary
This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.
Eligibility Criteria
Inclusion Criteria: 1. ≥6 and \<12 years old at the Screening visit (Visit 1) 2. Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential. 3. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C 4. Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement) 5. Meet the entry criteria assessed during the 2-week Screening period 6. Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device 7. Patient must provide verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedure