Opioid Use Clinical Trial
Official title:
Naloxegol for Opioid-Related Gastroparesis: A Double-Blind Study With an Open Label Extension
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.
Medicines can delay gastric emptying and produce similar symptoms to gastroparesis. In
particular, narcotic analgesics, can produce a gastroparesis picture, by delaying gastric
emptying. The slowing effect of opioids on gastric, small bowel, and colonic motility has
been well characterized. Unfortunately, many of these patients cannot stop their pain
medications due to their underlying condition, such as back pain, fibromyalgia. On top of
this, the narcotics can reduce the effectiveness of prokinetics agents used to treat
gastroparesis, such as metoclopramide and domperidone. At this time, there is no good
treatment for gastroparesis, especially for opioid-related gastroparesis.
Data suggests a relationship between opioid use and decreased gastric motility. Literature
suggests that peripherally acting opioid agonist may provide relief in the instance of GI
dysfunction (Holzer 2007). Movantik (Naloxegol) is an opioid agonist specifically designed to
work outside of the central nervous system. Movantik (Naloxegol) can alleviate the adverse
effects associated in chronic pain patients on opioid treatment - reduction of the undesired
peripheral effects of opioids without disrupting analgesic effects. The use of Movantik
(Naloxegol) has the potential to improve gastric dysmotility while preserving pain relief of
the opioid analgesic.
The objective of this study is to evaluate the effects of naloxegol in opioid-related
gastroparesis. This will be a randomized, double-blind study comparing Movantik 25 mg to
placebo. The dose of Movantik is the dose that is currently FDA approved for opioid-induced
constipation. The four-week study period is the duration of the phase 2b studies for Movantik
for opioid-induced constipation in which the response rates were 60% and 35% with active
treatment and placebo (Chey 2015).
The investigators have included a unique aspect of this study to better balance the benefits
for patients participating in this randomized double-blind study in which half the patients
receive a placebo agent. All patients in the treatment group and the placebo group will be
invited to participate in the 4-week open-label extension for this study. This also serves to
study the duration of the potential favorable effects of Movantik (Naloxegol) in this patient
population as well as offering an extended time period to assess safety and tolerability.
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