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Clinical Trials in the USA / NCT03720613
Recruiting Observational

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

NCT03720613 · tracked via the Priya Life Science USA tracker
Sponsor
BioDelivery Sciences International
Phase
Observational
Started
2019-01-04
Last updated
2026-09-30

Condition(s) studied

Opioid-induced Constipation

Investigational drug(s) / intervention(s)

Naldemedine →Lubiprostone →Naloxegol

Naldemedine: 0.2 mg tablet once a day at any time with or without food

Lubiprostone: 0.024 mg twice a day \[adjust dose based on liver function\]

Naloxegol: 25 mg tablet once a day in morning, 1 hour before or 2 hours after food

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants with a Major Adverse Cardiovascular Event — 5 years
    A composite of major adverse cardiovascular events, cardiovascular (CV) death, nonfatal myocardial infarction (MI), and non-fatal stroke; participants with major adverse cardiovascular events will be identified using claims data and the national death index.

Trial sites (1)

FacilityCityRegionStatus
Research Site Wilmington Delaware Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03720613 on ClinicalTrials.gov ↗ ← All trials in the USA