Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Opioid-induced Constipation
In brief
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.
Key facts
- Study ID
- NCT01050595
- Run by
- St. John Health System, Michigan
- People needed
- 80
- Starts
- 2009-12-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2010-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Providence Hospital and Medical Center — Southfield, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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