Naloxegol for Opioid-Related Gastroparesis

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Opioid-Induced, Delayed Gastric Emptying Read More

Inclusion Criteria:

1. Age 18-84, Males or Females
2. Daily use of narcotic analgesics for treatment of pain. Patients need to be on a stable daily dose of opiates for the last 4 weeks prior to enrollment
3. Patients with symptoms of gastroparesis with GCSI score (from the PAGI-SYM) of >2.0. These symptoms of gastroparesis must be present after starting opioid treatment.
4. Delayed gastric emptying based on previous scintigraphy (Percent gastric retention >60% at 2 hours and/or >10% retention at 4 hours
5. Signing informed consent prior to any study specific procedures

Exclusion Criteria:

1. Prior gastric resective surgery such as bariatric surgery, antrectomy.
2. Presence of severe renal impairment (CrCl<60 ml/min)
3. Presence of severe hepatic impairment - Child-Pugh Classification Class C, generally AST>200 or ALT>200 or Total bilirubin >3.0.
4. Other conditions besides gastroparesis that could potentially slow gastric emptying, such as untreated hypothyroidism.
5. Concomitants use of strong CYP 3A4 inhibitors (such as ketoconazole, diltiazem, erythromycin, clarithromycin), use of CYP3A4 inducer.
6. Use of NSAIDs and/or Plavix/Clopidogrel
7. Any prior use of Movantik (the study drug) or other opioid receptor antagonist (e.g., Relistor (methylnaltrexone), naltrexone, or naloxone) before the screening visit.
8. Patients with known cancer or cancer history within last 5 years prior to the screening visit.
9. Patients with GI obstruction and/or perforation or conditions with potential for GI perforation.
10. Patients with disruption to the blood-brain barrier;
11. Current use of a medication affecting gastric motility such as metoclopramide, domperidone, and erythromycin;
12. Pregnant women, females planning to become pregnant, and nursing mothers.
13. Women of childbearing potential who are unwilling to use contraceptives throughout the course of treatment
14. Subjects with severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic) based on PI's clinical judgment.
15. Active substance abuse.
16. History of major comorbid psychiatric conditions including mania and schizophrenia or severe current depression
17. At-risk populations, including prisoners and mentally challenged. Any condition or the patient is in a situation which may put him/her at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study (e.g., difficulty hearing, cognitive impairment)
18. Patients in which Movantik is clinically inadvisable
19. Subject unable to consent or is unwilling to provide informed consent