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Guanylate Cyclase-C Agonist

Plecanatide 3.0 mg for Chronic Constipation

Phase 3
Waitlist Available
Led By Richard A Krause, MD
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose up to 72 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Eligible Conditions
  • Chronic Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose up to 72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to 72 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide
Electrocardiogram
+5 more
Secondary study objectives
Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364
Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment
Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364
+1 more

Side effects data

From 2015 Phase 3 trial • 1410 Patients • NCT02122471
3%
Diarrhoea
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Plecanatide 3 mg
Plecanatide 6 mg
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plecanatide
FDA approved

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
79,560 Total Patients Enrolled
Syneos HealthOTHER
175 Previous Clinical Trials
66,131 Total Patients Enrolled
Richard A Krause, MDPrincipal InvestigatorClinSearch, LLC
~193 spots leftby Nov 2025
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