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

February 10, 2025 updated by: BioDelivery Sciences International

Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

34532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will include new users of naldemedine or one of the comparator OIC medications (lubiprostone or naloxegol) who satisfy all of the inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria:

  • At least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date)
  • At least two dispensings of opioids within six months prior to and including the index 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 and pharmacy benefits prior to and including the index date

Exclusion Criteria:

  • Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on the index date
  • Any cancer treatment or cancer pain diagnosis within six months before or on the index date
  • Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Naldemedine
Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
Drug: Naldemedine
0.2 mg tablet once a day at any time with or without food
Other Names:
  • Symproic®
Lubiprostone
Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
Drug: Lubiprostone
0.024 mg twice a day [adjust dose based on liver function]
Other Names:
  • Amitiza®
Naloxegol
Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.
Drug: Naloxegol
25 mg tablet once a day in morning, 1 hour before or 2 hours after food
Other Names:
  • Movantik®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a Major Adverse Cardiovascular Event
Time Frame: 5 years
A composite of major adverse cardiovascular events, cardiovascular (CV) death, nonfatal myocardial infarction (MI), and non-fatal stroke; participants with major adverse cardiovascular events will be identified using claims data and the national death index.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Cardiovascular Death
Time Frame: 5 years
Cardiovascular death is defined by the underlying cause of death and will include death from acute MI, sudden cardiac death, heart failure, stroke, cardiovascular procedure, cardiovascular hemorrhage, and other cardiovascular causes. Cardiovascular death will be identified using claims data and the national death index.
5 years
Number of Participants with Nonfatal Myocardial Infarction
Time Frame: 5 years
Participants with nonfatal myocardial infarction will be identified using claims data.
5 years
Number of Participants with Nonfatal Stroke
Time Frame: 5 years
Participants with nonfatal stroke will be identified using claims data.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioDelivery Sciences International

Collaborators

HealthCore, Inc.

Investigators

  • Principal Investigator: Stephen Lanes, HealthCore, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1711V9241

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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