Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

NCT03523520 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

Study results available
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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

Interventions

DRUG

Methylnaltrexone Bromide 150 mg Oral Tablet

Methylnaltrexone Bromide 150 mg Oral Tablet

DRUG

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

Methylnaltrexone Bromide 12 MG Subcutaneous Solution

DRUG

Naloxegol 25 MG Oral Tablet

Naloxegol 25 MG Oral Tablet

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • KARA B GODDARD, PharmD, BCPS · UNIVERSITY OF MISSOURI HEALTH CARE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523520 on ClinicalTrials.gov