NCT02706483

Long Term Safety Study of Plecanatide

An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,272 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, open-label, long-term safety study

Detailed description

This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled. Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals. Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments. Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Plecanatide

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2016-03-11
• Last updated: 2020-08-18
• Results posted: 2020-08-18

Locations

204 sites across 1 country: United States