Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

Constipation Drug Induced Clinical Trial

Official title:

Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523520
• Other study ID #: 2011409 HS
• Status: Completed
• Phase: Phase 4
• Start date: December 23, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation Drug Induced
• Opioid-Induced Constipation

Intervention

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

Locations

Country	Name	City	State
United States	Kara B. Goddard	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	Subcutaneous vs Oral	The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.	24 hours