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Completed

NCT Number: NCT03523520

Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

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.

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Key information

Conditions

Constipation Drug Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kara B. Goddard

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylnaltrexone Bromide 150 mg Oral Tablet

Drug

Methylnaltrexone Bromide 150 mg Oral Tablet

Other names: Relistor

Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1

Drug

Methylnaltrexone Bromide 12 MG Subcutaneous Solution

Other names: Relistor

Naloxegol 25 MG Oral Tablet

Drug

Naloxegol 25 MG Oral Tablet

Other names: Movantik

Primary outcomes

  1. 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

  1. Time to Bowl Movement Within 24 Hours

    Time frame: 24 hours after administration of study drug

    The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 14, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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