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Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Sponsor: BioDelivery Sciences International
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
Conditions
Interventions
Naldemedine
0.2 mg tablet once a day at any time with or without food
Lubiprostone
0.024 mg twice a day \[adjust dose based on liver function\]
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