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Movantik for Opioid-Related Esophageal Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998606
Recruitment Status : Terminated (Investigator left Institution)
First Posted : December 20, 2016
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Temple University

Brief 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. MOVANTIK™ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose, MOVANTIK™ (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 MOVANTIK™ (Naloxegol) in this patient population.

The investigational hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced esophageal motility disorders


Condition or disease Intervention/treatment Phase
Opioid-Induced Disorders Esophagus Disorder Drug: Naloxegol Drug: Placebo Oral Capsule Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Movantik for Opioid-Related Esophageal Disorders
Study Start Date : January 2017
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxegol

Arm Intervention/treatment
Experimental: Study Group
MOVANTIK™ (Naloxegol) 25 mg oral capsule, daily
Drug: Naloxegol
MOVANTIK™ 25 mg, daily
Other Name: Movantik

Placebo Comparator: Control Group
Placebo Oral Capsule 25 mg, daily
Drug: Placebo Oral Capsule
Placebo 25 mg, daily
Other Name: Placebo




Primary Outcome Measures :
  1. Manometric improvement in IRP (Integrated Relaxation Pressure) [ Time Frame: 28 days ]
    The effect of MOVANTIK™ (Naloxegol) on motor function, categorized as a 25% (mmHg) improvement in IRP (Integrated Relaxation Pressure) on high resolution esophageal manometry from baseline to visit three, comparing study group to placebo control group.


Secondary Outcome Measures :
  1. Overall Symptom Management [ Time Frame: 28 days ]
    Mean change from baseline to visit three in subject esophageal symptom scores according to the PAGI-SYM.

  2. Pain Management [ Time Frame: 28 days ]
    Mean change from baseline to visit three in subject esophageal symptom scores according to the McGill pain inventory.

  3. GERD Symptom Management [ Time Frame: 28 days ]
    Mean change from baseline to visit three in subject esophageal symptom scores according to the GERD symptom check list.

  4. Chest Pain Management [ Time Frame: 28 days ]
    Mean change from baseline to visit three in subject esophageal symptom scores according to the chest pain symptom questionnaire.

  5. Daily Symptom Management [ Time Frame: 28 days ]
    Mean change from baseline to visit three in subject esophageal symptom scores according to the daily diary

  6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: 42 days ]
    The occurrence of adverse events and early withdrawal in study group when compared to placebo control group to determine safety and tolerability.

  7. Quality of Life [ Time Frame: 28 days ]
    Mean change in patient-reported quality of life according to the SF-36



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Age 18-85, Males and Females
  3. On a stable daily opioid dose for various indications for at least 4 weeks prior to the HREM (High Resonance Esophageal Manometry
  4. Symptoms of odynophagia, dysphagia, or chest pain based on symptoms recorded on the PAGI-SYM

Exclusion Criteria:

  1. Renal impairment (cct<60) or severe Hepatic impairment as defined by the Child-Pugh Classification (Appendix J)
  2. Concomitant use of strong or moderate CYP3A4 inhibitors, strong CYP3A4 inducers, NSAIDS, Plavix/Clopidogrel and other opioid antagonists
  3. History of GI obstruction, bowel perforation, or with potential for either based on investigator's clinical judgment
  4. Subjects with known Barrett's esophagus or peptic stricture on endoscopy
  5. Subjects with previous upper gastrointestinal surgery
  6. Pregnant, plan to be pregnant, or are breastfeeding
  7. Women of childbearing potential who are unwilling to use contraceptives throughout the course of treatment
  8. 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
  9. Patients with an increased risk of gastrointestinal perforation due to conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g. peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
  10. Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)
  11. Patients taking baclofen or sucralfate and those unwilling to discontinue prohibited medications.
  12. Known history of substance abuse
  13. Subject unable to consent or is unwilling to provide informed consent
  14. History of major comorbid psychiatric conditions including mania and schizophrenia or severe current depression
  15. At-risk populations, including prisoners and mentally challenged. Any condition or 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)
  16. Known allergy to MOVANTIK™ (Naloxegol)
  17. Patients with a history of cancer within past 5 years prior to the screening visit
  18. Patients with a medical condition which may disrupt the blood-brain barrier

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998606


Locations
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United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
AstraZeneca
Investigators
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Principal Investigator: Ron Schey, MD Temple University
Publications:

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02998606    
Other Study ID Numbers: 23289
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Diseases
Disease
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Naloxegol
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents