RecruitingOpioid-induced Constipation
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: BioDelivery Sciences International
You may qualify if…
- ✓ 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 may not qualify if…
- ✕ 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
Where it's recruiting
Delaware
Wilmington
Source: ClinicalTrials.gov · NCT03720613 · last updated 2025-02-12