Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

Official title:
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

Status Enrolling by invitation

Clinical Trial Summary

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Constipation
Irritable Bowel Syndrome
Irritable Bowel Syndrome With Constipation (IBS-C)
Syndrome

Clinical Trial Details

NCT number	NCT05905926
Study type	Interventional
Source	Ardelyx
Contact
Status	Enrolling by invitation
Phase	Phase 3
Start date	February 17, 2023
Completion date	October 2031

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02316899` - Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome	Phase 3
Completed	`NCT02493036` - A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C	Phase 2
Completed	`NCT03471728` - Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
Recruiting	`NCT05643534` - Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years	Phase 3
Recruiting	`NCT05240521` - Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C	N/A
Completed	`NCT02495623` - A Study of the Effect of SYN-010 on Subjects With IBS-C	Phase 2
Completed	`NCT01880424` - A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)	Phase 3
Completed	`NCT02078323` - Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients	N/A