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The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit

NCT02705378 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-05-05

No results posted yet for this study

Summary

Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.

Conditions

Interventions

DRUG

Polyethylene glycol

Intervention would be given by oro-gastric (OG) or naso-gastric (NG) tube

DRUG

naloxegol

Intervention would be given by OG or NG tube

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Sadeq A. Quraishi, MD,MHA,MMSc · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-04-30
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02705378 on ClinicalTrials.gov