Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

University of Missouri (MU)

Status and phase: Completed; Phase 4

Conditions: Constipation Drug Induced

Treatments: Drug: Methylnaltrexone Bromide 150 mg Oral Tablet; Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1; Drug: Naloxegol 25 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03523520

2011409 HS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 3 patient groups

Methylnaltrexone oral tablets

Active Comparator group

Description:

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.

Treatment:

Drug: Methylnaltrexone Bromide 150 mg Oral Tablet

Methylnaltrexone subcutaneous injection

Active Comparator group

Description:

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.

Treatment:

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

Naloxegol oral tablets

Active Comparator group

Description:

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.

Treatment:

Drug: Naloxegol 25 MG Oral Tablet