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COMPLETED Phase 2

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

NCT03120520 · View on ClinicalTrials.gov ↗

Study Summary

This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.

Interventions

  • DRUG Matching placebo
  • DRUG Plecanatide

Study Locations (20)

California

  • Synergy Research Site — Cerritos
  • Synergy Research Site — Corona
  • Synergy Research Site — Downey
  • Synergy Research Site — Huntington Beach
  • Synergy Research Site — Sacramento
  • Synergy Research Site — Ventura

Florida

  • Synergy Research Site — DeLand
  • Synergy Research Site — Doral
  • Synergy Research Site — Hialeah
  • Synergy Research Site — Miami
  • Synergy Research Site — Orlando
  • Synergy Research Site — Tampa

Georgia

  • Synergy Research Site — Snellville
  • Synergy Research Site — Thomaston

Idaho

  • Synergy Research Site — Idaho Falls
  • Synergy Research Site — Meridian

Alabama

  • Synergy Research Site — Foley

Arkansas

  • Synergy Research Site — Jonesboro

Delaware

  • Synergy Research Site — Wilmington

Kentucky

  • Synergy Research Site — Nicholasville

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2017-01
Est. Completion 2018-09-07
Phase Phase 2

Sponsor

Bausch Health Americas

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03120520

The ClinicalTrials.gov registry entry for NCT03120520 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 2 interventions — of which Matching placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03120520 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03120520 about?

NCT03120520 is a clinical study titled "An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation". This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.

What is the current status of trial NCT03120520?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2017-01. Estimated completion is 2018-09-07.

What conditions does trial NCT03120520 study?

This clinical trial studies the following conditions: Chronic Idiopathic Constipation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03120520?

The interventions under investigation include: Matching placebo (DRUG), Plecanatide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03120520?

This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03120520 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial