NCT03720613

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

Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34,532 (estimated)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the National Death Index (NDI) to assess MACE risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator OIC medication. The uptake of naldemedine and comparator OIC medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. The safety assessment phase will commence at the conclusion of the monitoring phase.

Conditions

• Opioid-induced Constipation

Interventions

Type	Name	Description
DRUG	Naldemedine	0.2 mg tablet once a day at any time with or without food
DRUG	Lubiprostone	0.024 mg twice a day \[adjust dose based on liver function\]
DRUG	Naloxegol	25 mg tablet once a day in morning, 1 hour before or 2 hours after food

Timeline

• Start date: 2019-01-04
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2018-10-25
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study