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12-Week Study of Plecanatide for CIC (The CIC3 Study)

NCT01982240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1394

Last updated 2019-12-26

Study results available
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Summary

The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

Plecanatide

Plecanatide tablets QD for 12 weeks

DRUG

Placebo

Matching placebo tablets QD for 12 weeks

DRUG

Bisacodyl

Rescue medication

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Beth Layton · Synergy Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT01982240 on ClinicalTrials.gov