NCT03523520

Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation Drug Induced

Interventions

Type	Name	Description
DRUG	Methylnaltrexone Bromide 150 mg Oral Tablet	Methylnaltrexone Bromide 150 mg Oral Tablet
DRUG	Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1	Methylnaltrexone Bromide 12 MG Subcutaneous Solution
DRUG	Naloxegol 25 MG Oral Tablet	Naloxegol 25 MG Oral Tablet

Timeline

• Start date: 2020-12-23
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2018-05-14
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study