Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2023-03-31

Brief Summary

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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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Detailed Description

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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

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Constipation Drug Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of three groups i. Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection ii. Methylnaltrexone 12mg subcutaneous injection + placebo sugar tablets iii. Naloxegol oral tablets (total 25 mg) + subcutaneous water injection

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Each participant will be receiving one injection and tablets which have been randomly assigned.

Study Groups

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Methylnaltrexone oral tablets

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.

Group Type ACTIVE_COMPARATOR

Methylnaltrexone Bromide 150 mg Oral Tablet

Intervention Type DRUG

Methylnaltrexone Bromide 150 mg Oral Tablet

Methylnaltrexone subcutaneous injection

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Methylnaltrexone Bromide 12 MG Subcutaneous Solution

Naloxegol oral tablets

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.

Group Type ACTIVE_COMPARATOR

Naloxegol 25 MG Oral Tablet

Intervention Type DRUG

Naloxegol 25 MG Oral Tablet

Interventions

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Methylnaltrexone Bromide 150 mg Oral Tablet

Intervention Type DRUG

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

Methylnaltrexone Bromide 12 MG Subcutaneous Solution

Intervention Type DRUG

Naloxegol 25 MG Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Relistor Relistor Movantik

Eligibility Criteria

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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