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NCT01429987 · ClinicalTrials.gov registry record · Phase 2

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

A Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 2
Development phase
951
Enrollment target
20
Study locations

NCT01429987 is a Phase 2 study of Chronic Idiopathic Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 951 participants, above the 615-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT01429987, a Phase 2 study of Chronic Idiopathic Constipation, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 2
Development phase
951 participants
Enrollment target
20
Study locations

Study 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 Studied

Chronic Idiopathic Constipation

Interventions

  • OTHER Placebo
  • DRUG plecanatide

Study Locations (20)

California

  • ACRI-Phase 1,LLC - Anaheim
  • Translational Research Group, INC., d/b/a Providence Clinical Research - Burbank
  • GW Research, Inc - Chula Vista
  • Community Clinical Trials - Orange
  • Dormir Clinical Trials, Inc - Redlands
  • Inland Gastroenterology Medical Associates, Inc. - Redlands
  • Superior Research LLC - Sacramento
  • Medical Center for Clinical Research - San Diego
  • Medical Associates Research Group, Inc. - San Diego
  • Progressive Clinical Research - Vista

Arizona

  • East Valley Gastroenterology and Hepatology Associates, PC - Chandler
  • Genova Clinical Research - Tucson
  • Desert Sun Clinical Research, LLC - Tucson
  • Adobe Clinical Research, LLC - Tucson

Florida

  • Consultants for Clinical Research of S. Florida - Boynton Beach
  • Medical Research Unlimited, LLC - Hialeah
  • Nature Coast Clinical Research - Inverness

Alabama

  • Coastal Clinical Research, Inc. - Mobile

Arkansas

  • Preferred Research Partners, Inc - Little Rock

Colorado

  • Horizons Clinical Research Center, LLC - Denver

Trial Details

FieldValue
Enrollment Target 951 participants
Start Date 2011-10
Est. Completion 2012-12
Phase Phase 2

Sponsor

Bausch Health Americas

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01429987

The ClinicalTrials.gov registry entry for NCT01429987 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 951 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 615-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (55% higher). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01429987 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT01429987 about?

NCT01429987 is a clinical study titled "The Plecanatide Chronic Idiopathic Constipation (CIC) Study". 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).

What is the current status of trial NCT01429987?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 951 participants. The study started on 2011-10. Estimated completion is 2012-12.

What conditions does trial NCT01429987 study?

This clinical trial studies the following conditions: Chronic Idiopathic Constipation.

What interventions are being tested in trial NCT01429987?

The interventions under investigation include: Placebo (OTHER), plecanatide (DRUG).

Who is sponsoring clinical trial NCT01429987?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01429987 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.