Back to resultsAncillary Effects of Oral Naloxegol (Movantik)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naloxegol 25 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 18 years
- American Society of Anesthesiologists physical status 1-4;
- Scheduled for elective primary hip or knee surgery under spinal anesthesia;
- Expected to receive intravenous patient-controlled analgesia (IV PCA)
- Expected to have significant postoperative pain
- Negative pregnancy test
Exclusion Criteria:
- Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
- Severe renal impairment, or creatinine level > 2.0
- History of bladder cancer
- Patients receiving perioperative regional anesthesia blocks
- Presence of a sacral nerve stimulator
- Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
- Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
- Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
- Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
- 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
- Gastrointestinal obstruction/Gastrointestinal perforation
- Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
- Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
Sites / Locations
- The Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Arm
Placebo Arm
Arm Description
Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Outcomes
Primary Outcome Measures
Residual Urine Volume
Residual urine volume in the bladder as assessed by bladder scan
Secondary Outcome Measures
Side Effects of Naloxegol on Other Opioid Related Side Effects
Opioid-related Symptom Distress Scale (ORSDS) is a 4 point-scale that evaluates three symptom distress dimensions (frequency, severity, bothersomeness) for opioid-related side effects. The 12 elements of the ORSDS are nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, lightheaded, fatigue, feeling confused, itchiness, dry mouth, and headache. The ORSDS questionnaire was administered by a trained investigator on first and second postoperative days while patients remained hospitalized. We reported the average ORSDS score from all 12 elements, which ranged from 0 to 4 and higher scores represent worse outcome.
Need for Indwelling Urinary Catheterization
Number of patients receiving Naloxegol requiring indwelling urinary catheters
Quality of Recovery
Quality of recovery is a validated scoring system that quantifies patients' early postoperative health status with range of 0-150 where higher score means better quality of recovery. We used the 15-question version, the QoR-15
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235739
Brief Title
Ancillary Effects of Oral Naloxegol (Movantik)
Official Title
Ancillary Effects of Oral Naloxegol (Movantik)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Intervention Type
Drug
Intervention Name(s)
Naloxegol 25 MG
Other Intervention Name(s)
Movantik
Intervention Description
Oral Naloxegol 25 MG
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching oral placebo
Primary Outcome Measure Information:
Title
Residual Urine Volume
Description
Residual urine volume in the bladder as assessed by bladder scan
Time Frame
from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Secondary Outcome Measure Information:
Title
Side Effects of Naloxegol on Other Opioid Related Side Effects
Description
Opioid-related Symptom Distress Scale (ORSDS) is a 4 point-scale that evaluates three symptom distress dimensions (frequency, severity, bothersomeness) for opioid-related side effects. The 12 elements of the ORSDS are nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, lightheaded, fatigue, feeling confused, itchiness, dry mouth, and headache. The ORSDS questionnaire was administered by a trained investigator on first and second postoperative days while patients remained hospitalized. We reported the average ORSDS score from all 12 elements, which ranged from 0 to 4 and higher scores represent worse outcome.
Time Frame
Postoperative days 1-2 or until day of discharge whichever occurs first
Title
Need for Indwelling Urinary Catheterization
Description
Number of patients receiving Naloxegol requiring indwelling urinary catheters
Time Frame
Postoperative days 1-2 or until day of discharge whichever occurs first
Title
Quality of Recovery
Description
Quality of recovery is a validated scoring system that quantifies patients' early postoperative health status with range of 0-150 where higher score means better quality of recovery. We used the 15-question version, the QoR-15
Time Frame
Postoperative Days 2 or discharge day whichever was earlier
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Female or male aged at least 18 years
American Society of Anesthesiologists physical status 1-4;
Scheduled for elective primary hip or knee surgery under spinal anesthesia;
Expected to receive intravenous patient-controlled analgesia (IV PCA)
Expected to have significant postoperative pain
Negative pregnancy test
Exclusion Criteria:
Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
Severe renal impairment, or creatinine level > 2.0
History of bladder cancer
Patients receiving perioperative regional anesthesia blocks
Presence of a sacral nerve stimulator
Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
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
Gastrointestinal obstruction/Gastrointestinal perforation
Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet A Turan, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data to be provided in aggregate without patient identifiers
Learn more about this trial
Ancillary Effects of Oral Naloxegol (Movantik)
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