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NCT03720613 · ClinicalTrials.gov registry record

Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

A clinical trial of Opioid-induced Constipation, sponsored by BioDelivery Sciences International.

Recruiting
Registry status
34,532
Enrollment target
1
Study location

NCT03720613 is a study of Opioid-induced Constipation that is actively recruiting participants, run by BioDelivery Sciences International. The registered enrollment target is 34,532 participants, above the 326-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (10493% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT03720613, a study of Opioid-induced Constipation, is actively recruiting participants, sponsored by BioDelivery Sciences International.

RECRUITING
Registry status
34,532 participants
Enrollment target
1
Study location

Study Summary

The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.

Interventions

  • DRUG Naldemedine
  • DRUG Lubiprostone
  • DRUG Naloxegol

Study Locations (1)

Delaware

  • Research Site - Wilmington

Trial Details

FieldValue
Enrollment Target 34,532 participants
Start Date 2019-01-04
Est. Completion 2030-11-01

Sponsor

BioDelivery Sciences International

17 total trials

What the Registry Record Tells You About NCT03720613

The ClinicalTrials.gov registry entry for NCT03720613 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 34,532 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 326-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (10493% higher). The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 3 interventions - of which Naldemedine is the first listed.

NCT03720613 reports 1 study location spanning 1 distinct geographic area - top geographies include Delaware.

Frequently Asked Questions

What is clinical trial NCT03720613 about?

NCT03720613 is a clinical study titled "Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation". The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.

What is the current status of trial NCT03720613?

This trial is currently recruiting. The enrollment target is 34,532 participants. The study started on 2019-01-04. Estimated completion is 2030-11-01.

What conditions does trial NCT03720613 study?

This clinical trial studies the following conditions: Opioid-induced Constipation.

What interventions are being tested in trial NCT03720613?

The interventions under investigation include: Naldemedine (DRUG), Lubiprostone (DRUG), Naloxegol (DRUG).

Who is sponsoring clinical trial NCT03720613?

This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03720613 being conducted?

This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.