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

NCT ID: NCT03720613

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 34532 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2030-11-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Naldemedine

Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.

Naldemedine

Intervention Type: DRUG

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

Lubiprostone

Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.

Lubiprostone

Intervention Type: DRUG

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

Naloxegol

Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.

Naloxegol

Intervention Type: DRUG

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

Interventions

Naldemedine

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

Intervention Type: DRUG

Lubiprostone

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

Intervention Type: DRUG

Naloxegol

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

Intervention Type: DRUG

Other Intervention Names

Symproic®; Amitiza®; Movantik®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthCore, Inc.

INDUSTRY

Sponsor Role: collaborator

BioDelivery Sciences International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Lanes

Role: PRINCIPAL_INVESTIGATOR

HealthCore, Inc.

Locations

Research Site

Wilmington, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Todd Kunkel

Role: CONTACT

tkunkel@bdsi.com

913-940-1789

Tom Smith

Role: CONTACT

tsmith@bdsi.com

Other Identifiers

1711V9241

Identifier Type: -

Identifier Source: org_study_id