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Naloxegol and Opioid-induced Constipation

NCT03316859 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2022-05-05

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.

Conditions

Interventions

DRUG

Naloxegol 25 MG

Naloxegol 25 mg administered 1 hour pre-operatively

OTHER

Placebo pill

Placebo pill administered 1 hour pre-operatively

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Scott McCardle, MD · Bethesda North TriHealth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2022-12-01
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03316859 on ClinicalTrials.gov