Tenapanor for the Treatment of Pediatric Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome With Constipation (IBS-C)
About this trial
This is an interventional health services research trial for Irritable Bowel Syndrome With Constipation (IBS-C)
Eligibility Criteria
Inclusion Criteria: ≥6 and <18 years old at enrollment of either parent study Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence). Subject is ambulatory Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described Exclusion Criteria: Patient discontinued prematurely from the parent study. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy Pregnant or lactating women If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Sites / Locations
- G & L Research, LLC
- Advanced Research Center, Inc.
- Prohealth Research Center
- Valencia Medical and Research Center
- Florida Pharmaceutical Research and Associates, Inc.
- Frontier Clinical Research, LLC
- Frontier Clinical Research, LLC
- AIM Trials, LLC
- Sun Research Institute
- Frontier Clinical Research, LLC
Arms of the Study
Arm 1
Experimental
Tenapanor
Eligible 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 Investigator guidance after a patient's first week on the assigned dose.