Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

Recruiting now

Conditions studied: Opioid-induced Constipation

In brief

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.

Key facts

Study ID

NCT03720613

Run by

BioDelivery Sciences International

People needed

34532

Starts

2019-01-04

Expected to finish

2030-11-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 is running

• Research Site — Wilmington, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

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