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

Last updated: February 10, 2025
Sponsor: BioDelivery Sciences International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Treatment

Lubiprostone

Naloxegol

Naldemedine

Clinical Study ID

NCT03720613
1711V9241
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least one dispensing of naldemedine or lubiprostone or naloxegol without prioruse in the database of either medication (index date)

  • At least two dispensings of opioids within six months prior to and including theindex date, with at least a combined 31 cumulative days supply

  • At least 18 years of age or older on the index date

  • At least six months of continuous health plan coverage that includes medical andpharmacy benefits prior to and including the index date

Exclusion

Exclusion Criteria:

  • Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on theindex date

  • Any cancer treatment or cancer pain diagnosis within six months before or on theindex date

  • Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or onthe index date

Study Design

Total Participants: 34532
Treatment Group(s): 3
Primary Treatment: Lubiprostone
Phase:
Study Start date:
January 04, 2019
Estimated Completion Date:
November 01, 2030

Study Description

This is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the National Death Index (NDI) to assess MACE risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator OIC medication. The uptake of naldemedine and comparator OIC medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. The safety assessment phase will commence at the conclusion of the monitoring phase.

Connect with a study center

  • Research Site

    Wilmington, Delaware 19801
    United States

    Active - Recruiting

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