Movantik for Opioid-Related Esophageal Disorders (NCT02998606) | Clinical Trial Compass
TerminatedPhase 2
Movantik for Opioid-Related Esophageal Disorders
Stopped: Investigator left Institution
United States2 participantsStarted 2017-01
Plain-language summary
To date, few studies have assessed the effect of opioids on esophageal motility, mostly assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a large retrospective study assessing the effect of opioids on esophageal motility found that esophageal motor dysfunction are common in chronic opioid users whether studied on opioids and off opioids. In addition, current opioid users also had significantly higher integrated relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli 2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal transit without affecting the centrally mediated analgesic effects. MOVANTIKā¢ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. MOVANTIKā¢ (Naloxegol) has been recently approved for opioid-induced constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose, MOVANTIKā¢ (Naloxegol) is effective and safe, with a limited side effect profile and is associated with preservation of centrally mediated analgesia.
This study will explore the safety and tolerability of MOVANTIKā¢ (Naloxegol) in this patient population.
The investigational hypothesis is that MOVANTIKā¢ (Naloxegol) could improve opioid- induced esophageal motility disorders
Who can participate
Age range18 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Provision of informed consent prior to any study specific procedures
ā. Age 18-85, Males and Females
ā. On a stable daily opioid dose for various indications for at least 4 weeks prior to the HREM (High Resonance Esophageal Manometry
ā. Symptoms of odynophagia, dysphagia, or chest pain based on symptoms recorded on the PAGI-SYM
Exclusion criteria
ā. Renal impairment (cct\<60) or severe Hepatic impairment as defined by the Child-Pugh Classification (Appendix J)
ā. Concomitant use of strong or moderate CYP3A4 inhibitors, strong CYP3A4 inducers, NSAIDS, Plavix/Clopidogrel and other opioid antagonists
ā. History of GI obstruction, bowel perforation, or with potential for either based on investigator's clinical judgment
ā. Subjects with known Barrett's esophagus or peptic stricture on endoscopy
ā. Subjects with previous upper gastrointestinal surgery
What they're measuring
1
Manometric improvement in IRP (Integrated Relaxation Pressure)
ā. Pregnant, plan to be pregnant, or are breastfeeding
ā. Women of childbearing potential who are unwilling to use contraceptives throughout the course of treatment
ā. Subjects with serious co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic) which may prevent the patient to participate in the study based on PI's clinical judgment or malignancy