Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit (MOVE-IT)

St. John Health System, Michigan

Status and phase

Unknown

Phase 3

Conditions

Opioid-induced Constipation

Treatments

Drug: Placebo-Normal Saline

Drug: Methylnaltrexone Bromide

Study type

Interventional

Funder types

Other

Identifiers

NCT01050595

107199

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older in the ICU
Opioids for analgesia for at least 24 hours.
Opioid-induced constipation with no bowel movement within the last 72 hours.
Women of childbearing potential had negative pregnancy tests.

Exclusion criteria

Contraindication to use of the GI tract
Diarrhea on admission
Bowel surgery within 8 weeks of admission
Ileostomy or colostomy
Not expected to live or stay more than 3 days in the intensive care unit
Constipation that was not primarily caused by opioids (as determined by the investigator)
No opioid use in the last 24 hours,
Mechanical gastrointestinal obstruction
An indwelling peritoneal catheter
Clinically active diverticular disease
Fecal impaction
Acute surgical abdomen
History of Crohn's disease or ulcerative colitis
On Palliative care
Less than 18 years old
Bowel movement in last 72 hours.