Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Recruiting at 168 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bausch Health Americas, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Research Team
RA
Richard A Krause, MD
Principal Investigator
ClinSearch, LLC
Eligibility Criteria
Inclusion Criteria
Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.
Treatment Details
Interventions
- Plecanatide (Guanylate Cyclase-C Agonist)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Plecanatide 6.0 mgExperimental Treatment1 Intervention
Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks
Group II: Plecanatide 3.0 mgExperimental Treatment1 Intervention
Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bausch Health Americas, Inc.
Lead Sponsor
Trials
265
Recruited
82,000+
Dr. Jonathan Sadeh
Bausch Health Americas, Inc.
Chief Medical Officer
MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School
Thomas J. Appio
Bausch Health Americas, Inc.
Chief Executive Officer since 2021
Bachelor's degree in Biology from Rutgers University
Syneos Health
Collaborator
Trials
181
Recruited
69,600+