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

S

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Methylnaltrexone Bromide
Active Comparator group
Treatment:
Drug: Methylnaltrexone Bromide
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo-Normal Saline

Trial contacts and locations

1

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Central trial contact

Bradford A Whitmer, D.O.

Data sourced from clinicaltrials.gov

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