Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

NCT03523520 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2011409 HS
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation Drug Induced

Keywords

constipation; opioid

Outcome Measures

Primary Outcomes (1)

• Occurrence of Bowl 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.

  24 hours

Secondary Outcomes (1)

• Time to Bowl Movement Within 24 Hours

  24 hours after administration of study drug

Study Arms (3)

Methylnaltrexone oral tablets

ACTIVE COMPARATOR

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.

Drug: Methylnaltrexone Bromide 150 mg Oral Tablet

Methylnaltrexone subcutaneous injection

ACTIVE COMPARATOR

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.

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

Naloxegol oral tablets

ACTIVE COMPARATOR

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.

Drug: Naloxegol 25 MG Oral Tablet

Interventions

Methylnaltrexone Bromide 150 mg Oral Tablet DRUG

Methylnaltrexone Bromide 150 mg Oral Tablet

Also known as: Relistor

Methylnaltrexone oral tablets

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

Methylnaltrexone Bromide 12 MG Subcutaneous Solution

Also known as: Relistor

Methylnaltrexone subcutaneous injection

Naloxegol 25 MG Oral Tablet DRUG

Naloxegol 25 MG Oral Tablet

Also known as: Movantik

Naloxegol oral tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age\<18y/o
• Pregnancy or lactation
• Contraindication to Methylnaltrexone or Naloxegol
• Assigned NPO
• Small bowel obstruction

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Kara B. Goddard

Columbia, Missouri, 65212, United States

Location

Related Publications (3)

• 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.

  PMID: 29207909 BACKGROUND

• 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.

  PMID: 26150678 RESULT

• 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.

  PMID: 26312011 RESULT

MeSH Terms

Conditions

Constipation

Interventions

methylnaltrexone; Tablets; naloxegol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Kara B. Goddard
• Organization: University of Missouri Health Care

goddardk@health.missouri.edu

5738841605

Study Officials

• KARA B GODDARD, PharmD, BCPS

  UNIVERSITY OF MISSOURI HEALTH CARE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each participant will be receiving one injection and tablets which have been randomly assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Model Details: 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

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: December 23, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)