An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome with Constipation (Ibs-C) in Pediatric Patients 6 to Less Than 18 Years Old

Investigating Safety of Investigational Medication for Irritable Bowel Syndrome with Constipation (IBS-C) in Children

E
Erik David Andrewski

Primary Investigator

Enrolling By Invitation
6 years - 17 years
All
Phase N/A
2 participants needed
2 Locations

Brief description of study

The primary objective of this study is to assess the safety and tolerability of tenapanor for the treatment of IBS-C in pediatric patients (more than or equal to 6 and <18 years old) when administered BID for up to 40 weeks.

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Irritable Bowel Syndrome with Constipation (IBS-C), Riley
  • Age: 6 years - 17 years
  • Gender: All

Inclusion Criteria:

  1. ≥6 and <18 years old at enrollment of either parent study
  2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
  3. 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).
  4. Subject is ambulatory
  5. 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:

  1. Patient discontinued prematurely from the parent study.
  2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
  3. Pregnant or lactating women
  4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

This study investigates the safety and tolerability of an investigational medication for treating Irritable Bowel Syndrome with Constipation (IBS-C) in children aged 6 to less than 18 years. IBS-C is a condition where children experience stomach pain and difficulty in passing stools. The purpose of this study is to observe if the investigational medication is safe when taken twice a day for up to 40 weeks.

During the study, children will visit the clinic approximately every six weeks. These visits will include safety checks like physical exams, heart tests (ECG), and lab tests to monitor health. The study will also track any side effects and other medications taken by participants. Medication will be provided based on each child's daily dose, and compliance will be monitored.

  • Who can participate: Children aged 6 to less than 18 years who have completed a prior related study and are compliant with study procedures can participate. Female participants must have a negative pregnancy test and use contraception.
  • Study details: Participants will take the investigational medication twice daily and attend clinic visits for safety assessments. All participants will receive the investigational medication.
  • Study timelines and visits: The study will last up to 40 weeks. The study requires approximately 7 visits.
Updated on 18 Feb 2026. Study ID: PGI-ARDELYX-TEN-01-306, 29207
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only