DRUG
Status
Completed
Phase
Phase 3
Enrollment
2,272
Locations
204
Results
Posted
Publications
1
Study summary
What the protocol is testing.
Multi-center, open-label, long-term safety study
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 11, 2016
Study start
Jan 2016
Primary completion
May 2017
Study completion
Jun 2017
Results posted
Aug 18, 2020
Registry updated
Aug 18, 2020
Outcomes
What the study measures.
Primary outcomes
Number of Participants With Treatment Related Adverse Events.
Time frame · up to 53 weeks
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
204 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Synergy Research Site
Athens, Alabama, United States
Synergy Research Site
Birmingham, Alabama, United States
Synergy Research Site
Dothan, Alabama, United States
Synergy Research Site
Foley, Alabama, United States
Synergy Research Site
Guntersville, Alabama, United States
Synergy Research Site
Huntsville, Alabama, United States
Synergy Research Site
Saraland, Alabama, United States
Synergy Research Site
Chandler, Arizona, United States
Synergy Research Site
Phoenix, Arizona, United States
Synergy Research Site
Surprise, Arizona, United States
Synergy Research Site
Tucson, Arizona, United States
Synergy Research Site
Conway, Arkansas, United States
Synergy Research Site
Glendale, Arkansas, United States
Synergy Research Site
Little Rock, Arkansas, United States
Synergy Research Site
Artesia, California, United States
Synergy Research Site
Canoga Park, California, United States
Synergy Research Site
Carmichael, California, United States
Synergy Research Site
Chula Vista, California, United States
Synergy Research Site
Corona, California, United States
Synergy Research Site
Costa Mesa, California, United States
Synergy Research Site
El Cajon, California, United States
Synergy Research Site
Encino, California, United States
Synergy Research Site
Foothill Ranch, California, United States
Synergy Research Site
Fountain Valley, California, United States
Publications
Results and literature.
Related trials
More studies on Plecanatide.
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Phase 2
Completed
218
2025-12
Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
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Phase 3
Completed
648
2024-07
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
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Phase 2
Completed
84
2020-01
12-Week Study of Plecanatide for CIC (The CIC3 Study)
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Phase 3
Completed
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2019-12
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
Bausch Health Americas, Inc. · Chronic Idiopathic Constipation
Not applicable
Completed
7
2019-11
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Bausch Health Americas, Inc. · Chronic Idiopathic Constipation
Phase 2
Completed
124
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.