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

NCT03720613 | Recruiting FDA Drug

• 1 other identifier: 1711V9241
• Study Type: observational
• Target: 34,532
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-induced Constipation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with a Major Adverse Cardiovascular Event

  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.

  5 years

Secondary Outcomes (3)

• Number of Participants with Cardiovascular Death

  5 years

• Number of Participants with Nonfatal Myocardial Infarction

  5 years

• Number of Participants with Nonfatal Stroke

  5 years

Study Arms (3)

Naldemedine

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

Drug: Naldemedine

Lubiprostone

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

Drug: Lubiprostone

Naloxegol

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

Drug: Naloxegol

Interventions

Naldemedine DRUG

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

Also known as: Symproic®

Naldemedine

Lubiprostone DRUG

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

Also known as: Amitiza®

Lubiprostone

Naloxegol DRUG

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

Also known as: Movantik®

Naloxegol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include new users of naldemedine or one of the comparator OIC medications (lubiprostone or naloxegol) who satisfy all of the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioDelivery Sciences International: lead
• HealthCore, Inc.: collaborator

Study Sites (1)

Research Site

Wilmington, Delaware, 19801, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naldemedine; Lubiprostone; naloxegol

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Stephen Lanes

  HealthCore, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Kunkel

CONTACT

913-940-1789; tkunkel@bdsi.com

Tom Smith

CONTACT

tsmith@bdsi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: January 4, 2019
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)