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The Plecanatide Chronic Idiopathic Constipation (CIC) Study

NCT01429987 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 951

Last updated 2019-05-28

Study results available
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Summary

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

plecanatide

Subjects receive experimental study drug for 12 weeks.

OTHER

Placebo

Subjects receive experimental study drug for 12 weeks.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01429987 on ClinicalTrials.gov