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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03523520
Other study ID # 2011409 HS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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Recruiting NCT04876508 - The Efficacy of Acupressure in Managing Opioid-induced Constipation N/A
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