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Opioid Antagonist
Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit (MOVE-IT Trial)
Phase 3
Waitlist Available
Led By Bradford A Whitmer, D.O.
Research Sponsored by St. John Health System, Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
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.
Eligible Conditions
- Constipation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Methylnaltrexone BromideActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
St. John Health System, MichiganLead Sponsor
5 Previous Clinical Trials
2,059 Total Patients Enrolled
Bradford A Whitmer, D.O.Principal InvestigatorProvidence Hospital and Medical Center