Long Term Safety Study of Plecanatide

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Plecanatide

• Registration Number: NCT02706483
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Disposition First Submitted: 2019-05-23
• Disposition First Submitted QC: 2019-05-23
• Disposition First Posted: 2019-05-31
• Status Verified: 2020-08
• Results First Submitted: 2020-08-05
• Results First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Results First Posted: 2020-08-18
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2272

Inclusion Criteria

Patients with documented diagnosis of IBS-C who:

• Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
• Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key

Exclusion Criteria

• Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
• Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
• Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
• Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
• In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plecanatide	Plecanatide	Plecanatide 6.0 mg tablets

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Related Adverse Events.	up to 53 weeks	Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.

Trial Locations

Locations (2)

Synergy Research Site; 🇺🇸 Milwaukee, Wisconsin, United States

Synergy Research Site.; 🇺🇸 Charlotte, North Carolina, United States