Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
- Conditions
- Constipation Drug Induced
- Interventions
- Registration Number
- NCT03523520
- Lead Sponsor
- University of Missouri-Columbia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- Age<18y/o
- Pregnancy or lactation
- Contraindication to Methylnaltrexone or Naloxegol
- Assigned NPO
- Small bowel obstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylnaltrexone oral tablets Methylnaltrexone Bromide 150 mg Oral Tablet 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. Naloxegol oral tablets Naloxegol 25 MG Oral Tablet 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. Methylnaltrexone subcutaneous injection Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 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.
- Primary Outcome Measures
Name Time Method Occurrence of Bowl Movement 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 Outcome Measures
Name Time Method Time to Bowl Movement Within 24 Hours 24 hours after administration of study drug The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.
Trial Locations
- Locations (1)
Kara B. Goddard
🇺🇸Columbia, Missouri, United States