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
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Delaware
Research Site
RECRUITING
Wilmington
Contact Information
Primary
Todd Kunkel
tkunkel@bdsi.com
913-940-1789
Backup
Tom Smith
tsmith@bdsi.com
Time Frame
Start Date: 2019-01-04
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 34532
Treatments
Naldemedine
Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
Lubiprostone
Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
Naloxegol
Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.
Related Therapeutic Areas
Sponsors
Collaborators: HealthCore, Inc.
Leads: BioDelivery Sciences International