Overview

Naloxegol for Opioid-Related Gastroparesis

Status:
Withdrawn
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of gastroparesis; 2) gastric emptying; and 3) pain control. The endpoints will be gastroparesis symptoms (PAGI-SYM), gastric emptying (GEBT), and pain control (McGill Pain Inventory). The hypothesis to be tested is that naloxegol improves symptoms of gastroparesis in patients who are taking opioids as well as improves their gastric emptying while maintaining control of patient's pain. This study will entail an initial double-blind, randomized, placebo-controlled, 4-week treatment period of naloxegol vs placebo in patients with opioid-related gastroparesis followed by a 4-week open label period to demonstrate the improvement in symptoms and gastric emptying with naloxegol.
Phase:
Phase 2
Details
Lead Sponsor:
Temple University
Collaborator:
AstraZeneca
Treatments:
Analgesics, Opioid
Naloxegol