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RECRUITING
NCT03720613

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

Sponsor: BioDelivery Sciences International

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

34532

Start Date

2019-01-04

Completion Date

2030-11-01

Last Updated

2025-02-12

Healthy Volunteers

No

Interventions

DRUG

Naldemedine

0.2 mg tablet once a day at any time with or without food

DRUG

Lubiprostone

0.024 mg twice a day \[adjust dose based on liver function\]

DRUG

Naloxegol

25 mg tablet once a day in morning, 1 hour before or 2 hours after food

Locations (1)

Research Site

Wilmington, Delaware, United States