Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induce… (NCT03720613) | Clinical Trial Compass
RecruitingNot Applicable
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
United States34,532 participantsStarted 2019-01-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Number of Participants with a Major Adverse Cardiovascular Event