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Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

Primary Purpose

Constipation Drug Induced

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylnaltrexone Bromide 150 mg Oral Tablet
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1
Naloxegol 25 MG Oral Tablet
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation Drug Induced focused on measuring constipation, opioid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kara B. Goddard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Methylnaltrexone oral tablets

Methylnaltrexone subcutaneous injection

Naloxegol oral tablets

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Time to Bowel Movement
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

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

Full Information

First Posted
May 1, 2018
Last Updated
April 6, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03523520
Brief Title
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
Official Title
Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation Drug Induced
Keywords
constipation, opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
Each participant will be receiving one injection and tablets which have been randomly assigned.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylnaltrexone oral tablets
Arm Type
Active Comparator
Arm 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.
Arm Title
Methylnaltrexone subcutaneous injection
Arm Type
Active Comparator
Arm 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.
Arm Title
Naloxegol oral tablets
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone Bromide 150 mg Oral Tablet
Other Intervention Name(s)
Relistor
Intervention Description
Methylnaltrexone Bromide 150 mg Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1
Other Intervention Name(s)
Relistor
Intervention Description
Methylnaltrexone Bromide 12 MG Subcutaneous Solution
Intervention Type
Drug
Intervention Name(s)
Naloxegol 25 MG Oral Tablet
Other Intervention Name(s)
Movantik
Intervention Description
Naloxegol 25 MG Oral Tablet
Primary Outcome Measure Information:
Title
Time to Bowel Movement
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Subcutaneous vs Oral
Description
The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KARA B GODDARD, PharmD, BCPS
Organizational Affiliation
UNIVERSITY OF MISSOURI HEALTH CARE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kara B. Goddard
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29207909
Citation
Bowers BL, Crannage AJ. The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. J Pharm Pract. 2019 Oct;32(5):558-567. doi: 10.1177/0897190017745395. Epub 2017 Dec 5.
Results Reference
background
PubMed Identifier
26150678
Citation
Jones R, Prommer E, Backstedt D. Naloxegol: A Novel Therapy in the Management of Opioid-Induced Constipation. Am J Hosp Palliat Care. 2016 Nov;33(9):875-880. doi: 10.1177/1049909115593937. Epub 2015 Jul 6.
Results Reference
result
PubMed Identifier
26312011
Citation
Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.
Results Reference
result

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Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

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