Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT02998606
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02998606
Study Brief:
Protocol Section:
NCT02998606