Actively Recruiting
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Led by BioDelivery Sciences International · Updated on 2025-02-12
34532
Participants Needed
1
Research Sites
617 weeks
Total Duration
On this page
Sponsors
B
BioDelivery Sciences International
Lead Sponsor
H
HealthCore, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Wilmington, Delaware, United States, 19801
Actively Recruiting
Research Team
T
Todd Kunkel
CONTACT
T
Tom Smith
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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