Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Occurrence of Bowl Movement
Study Overview
Brief Summary
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
Detailed Description
Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Each participant will be receiving one injection and tablets which have been randomly assigned.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)
- •Age≥18y/o
- •Not pregnant or lactating (negative urinary pregnancy test)
- •No contraindication to Methylnaltrexone or Naloxegol
Exclusion Criteria
- •Age<18y/o
- •Pregnancy or lactation
- •Contraindication to Methylnaltrexone or Naloxegol
- •Assigned NPO
- •Small bowel obstruction
Arms & Interventions
Methylnaltrexone oral tablets
Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Intervention: Methylnaltrexone Bromide 150 mg Oral Tablet (Drug)
Methylnaltrexone subcutaneous injection
Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Intervention: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 (Drug)
Naloxegol oral tablets
Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Intervention: Naloxegol 25 MG Oral Tablet (Drug)
Outcomes
Primary Outcomes
Occurrence of Bowl Movement
Time Frame: 24 hours
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
Secondary Outcomes
- Time to Bowl Movement Within 24 Hours(24 hours after administration of study drug)
Investigators
Kara B. Goddard, PharmD, BCPS
Clinical Pharmacy Specialist
University of Missouri-Columbia