RECRUITING

Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain

Talk to us

Conditions

Opioid-induced Constipationnaloxegolmajor adverse cardiovascular event (MACE)opioid induced constipation (OIC)lubiprostonenaldemedine

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-01-04
Study Completion:2030-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03720613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date)
  2. * 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
  3. * At least 18 years of age or older on the index date
  4. * At least six months of continuous health plan coverage that includes medical and pharmacy benefits prior to and including the index date
  1. * Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on the index date
  2. * Any cancer treatment or cancer pain diagnosis within six months before or on the index date
  3. * Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date

Contacts and Locations

Study Contact

Todd Kunkel
CONTACT
913-940-1789
tkunkel@bdsi.com
Tom Smith
CONTACT
tsmith@bdsi.com

Principal Investigator

Stephen Lanes
PRINCIPAL_INVESTIGATOR
HealthCore, Inc.

Study Locations (Sites)

Research Site
Wilmington, Delaware, 19801
United States

Collaborators and Investigators

Sponsor: BioDelivery Sciences International

  • Stephen Lanes, PRINCIPAL_INVESTIGATOR, HealthCore, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-04
Study Completion Date2030-11-01

Study Record Updates

Study Start Date2019-01-04
Study Completion Date2030-11-01

Terms related to this study

Keywords Provided by Researchers

  • naloxegol
  • major adverse cardiovascular event (MACE)
  • opioid induced constipation (OIC)
  • lubiprostone
  • naldemedine

Additional Relevant MeSH Terms

  • Opioid-induced Constipation