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Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

NCT01050595 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-01-15

No results posted yet for this study

Summary

The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.

Conditions

  • Opioid-induced Constipation

Interventions

DRUG

Methylnaltrexone Bromide

The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. If creatinine clearance \<30 will decrease dose by 50%. This will be given after 72 hours of no bowel movement. Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day.

DRUG

Placebo-Normal Saline

Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs. A bowel management protocol will also be started.

Sponsors & Collaborators

  • St. John Health System, Michigan

    lead OTHER

Principal Investigators

  • Bradford A Whitmer, D.O. · Providence Hospital and Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-10-31
Completion
2010-12-31

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 NCT01050595 on ClinicalTrials.gov