MedTrace Logo

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

NCT01919697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2370

Last updated 2019-07-02

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

Plecanatide

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard A Krause, MD · ClinSearch, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01919697 on ClinicalTrials.gov