Clinical trial NCT03235739: Ancillary Effects of Oral Naloxegol (Movantik)
Official title: Ancillary Effects of Oral Naloxegol (Movantik)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effect of Naloxegol on reversing opioid-related side effects in patients recovering from elective primary hip surgery under spinal anesthesia who will be randomly assigned to oral Naloxegol or placebo for two postoperative days or until the date of discharge, whichever occurs earlier. The design will be a randomized, double-blind, placebo-controlled trial of oral Naloxegol in adults having elective primary hip or knee surgery under spinal anesthesia. The study will be performed at the Cleveland Clinic hospitals.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether oral Naloxegol can reduce the side effects of opioid painkillers following surgery. This study aims to explore whether Naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery patients will participate in this study which is being conducted at Cleveland Clinic Main Campus.

Detailed description: Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged at least 18 years
3. American Society of Anesthesiologists physical status 1-4;
4. Scheduled for elective primary hip or knee surgery under spinal anesthesia;
5. Expected to receive intravenous patient-controlled analgesia (IV PCA)
6. Expected to have significant postoperative pain
7. Negative pregnancy test

Exclusion Criteria:

1. Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
2. Severe renal impairment, or creatinine level \> 2.0
3. History of bladder cancer
4. Patients receiving perioperative regional anesthesia blocks
5. Presence of a sacral nerve stimulator
6. Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
7. Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
8. Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
9. Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
10. Patients with known or suspected disruption of blood brain barrier, which may include but not limited to: Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, and Parkinson's disease
11. Gastrointestinal obstruction/Gastrointestinal perforation
12. Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
13. Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients

Primary outcomes:
measure: Residual Urine Volume
timeFrame: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Secondary outcomes:
measure: Side Effects of Naloxegol on Other Opioid Related Side Effects
timeFrame: Postoperative days 1-2 or until day of discharge whichever occurs first
measure: Need for Indwelling Urinary Catheterization
timeFrame: Postoperative days 1-2 or until day of discharge whichever occurs first
measure: Quality of Recovery
timeFrame: Postoperative Days 2 or discharge day whichever was earlier
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mehmet A Turan, MD
role: PRINCIPAL_INVESTIGATOR
References: