Actively Recruiting
Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications for Opioid Induced Constipation in Adults with Chronic Non-Cancer Pain
Led by BioDelivery Sciences International · Updated on 2025-02-12
34532
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
BioDelivery Sciences International
Lead Sponsor
H
HealthCore, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the risk of major adverse cardiovascular events (MACE) in adults with chronic non-cancer pain who use medications for opioid-induced constipation (OIC). The study compares new users of naldemedine with new users of lubiprostone and naloxegol, aiming to understand cardiovascular risks associated with these treatments. This observational study uses multiple databases linked to medical records and the National Death Index to monitor outcomes over time. Participants are grouped based on which OIC medication they start: naldemedine (0.2 mg once daily), lubiprostone (0.024 mg twice daily, dose adjusted for liver function), or naloxegol (25 mg once daily in the morning). The study tracks the uptake of these medications annually until enough patient data is gathered to begin the safety assessment phase, focusing on cardiovascular events. During the study, researchers will monitor participants for five years to count the number who experience major adverse cardiovascular events, including cardiovascular death, nonfatal heart attacks, and strokes. Data collection involves reviewing healthcare claims and medical records. The study helps evaluate the cardiovascular safety of these medications in patients with chronic pain taking opioids.
CONDITIONS
Brief 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, lubiprostone, or naloxegol without prior use of these medications in the database (index date)
- At least two opioid dispensings within six months prior to and including the index date, totaling at least 31 cumulative days supply
- Age 18 years or older on the index date
- At least six months of continuous health plan coverage including medical and pharmacy benefits before and including the index date
You will not qualify if you...
- Any acute major adverse cardiovascular event (non-fatal heart attack or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 5 years
Participants who initiate treatment with naldemedine, lubiprostone, or naloxegol for opioid-induced constipation are observed to assess cardiovascular safety outcomes over time.
Periodic assessments through medical records and databases; no additional visits required
Trial Site Locations
Total: 1 location
1
Research Site
Wilmington, Delaware, United States, 19801
Actively Recruiting
Research Team
T
Todd Kunkel
T
Tom Smith
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
Frequently Asked Questions
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