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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Long Term Safety Study of Plecanatide

Short name IBS-C

NCTNCT02706483 (opens ClinicalTrials.gov in a new tab)Other idSP304203-06
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,272 participants (actual)
Sponsor
Bausch Health Americas, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2016
Primary completion
May 2017
Completion
Jun 2017
First posted
11 Mar 2016 (estimated)
Last update posted
18 Aug 2020
Conditions
Irritable Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 3

    IBS-C

    NCT02706483

    Jan 2016 to Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PlecanatideDrug

Arms1

  • Experimental

    Plecanatide

    Plecanatide 6.0 mg tablets

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment Related Adverse Events.

    Time frame · up to 53 weeks

    Registry description

    Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· up to 53 weeks

Number of Participants With Treatment Related Adverse Events.

GroupValue (Participants)
Plecanatide205

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlecanatidePlecanatide 6.0 mg tablets Plecanatide1 / 227245 / 2272341 / 2272

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2019

10 results

Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation.

Barish et al. 2019Current medical research and opinioncited by 5

PMID 30277094DOI 10.1080/03007995.2018.1527303PUB-30277094

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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