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Clinical Trials/NCT03523520
NCT03523520CompletedPhase 4

Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department

University of Missouri-Columbia1 site in 1 country15 target enrollmentStarted: December 23, 2020Last updated:
Conditions
Interventions
Drugs

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kara B. Goddard, PharmD, BCPS

Clinical Pharmacy Specialist

University of Missouri-Columbia

Study Sites (1)

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