Ancillary Effects of Oral Naloxegol (Movantik)

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Naloxegol 25 MG; Drug: Placebo

• Registration Number: NCT03235739
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Study Start: 2017-10-01
• Primary Completion: 2021-05-31
• Study Completion: 2022-05-23
• Results First Submitted: 2022-09-14
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-14
• Results First Posted: 2023-09-05
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Naloxegol 25 MG	Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Placebo Arm	Placebo	Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

Primary Outcome Measures

Name	Time	Method
Residual Urine Volume	from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first	Residual urine volume in the bladder as assessed by bladder scan

Secondary Outcome Measures

Name	Time	Method
Need for Indwelling Urinary Catheterization	Postoperative days 1-2 or until day of discharge whichever occurs first	Number of patients receiving Naloxegol requiring indwelling urinary catheters
Quality of Recovery	Postoperative Days 2 or discharge day whichever was earlier	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
Side Effects of Naloxegol on Other Opioid Related Side Effects	Postoperative days 1-2 or until day of discharge whichever occurs first	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.

Trial Locations

Locations (1)

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States