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

NCT03720613 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34532

Last updated 2025-02-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • HealthCore, Inc.

    collaborator INDUSTRY

  • BioDelivery Sciences International

    lead INDUSTRY

Principal Investigators

  • Stephen Lanes · HealthCore, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2030-11-01
Completion
2030-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720613 on ClinicalTrials.gov