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Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
RECRUITINGSponsored by BioDelivery Sciences International
Actively Recruiting
SponsorBioDelivery Sciences International
Started2019-01-04
Est. completion2030-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03720613
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
CancerOpioid-induced Constipation
Locations1 site
Research Site
Wilmington, Delaware, 19801
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Actively Recruiting
SponsorBioDelivery Sciences International
Started2019-01-04
Est. completion2030-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03720613