NCT02727751

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

Detailed description

During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.

Conditions

• Constipation Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Tenapanor

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-04-05
• Last updated: 2020-09-09
• Results posted: 2020-04-24

Locations

1 site across 1 country: United States