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Completed

NCT Number: NCT03235739

Ancillary Effects of Oral Naloxegol (Movantik)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxegol 25 MG

Drug

Oral Naloxegol 25 MG

Other names: Movantik

Placebo

Drug

matching oral placebo

Primary outcomes

  1. Residual Urine Volume

    Time frame: 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 outcomes

  1. Side Effects of Naloxegol on Other Opioid Related Side Effects

    Time frame: 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.

  2. Need for Indwelling Urinary Catheterization

    Time frame: Postoperative days 1-2 or until day of discharge whichever occurs first

    Number of patients receiving Naloxegol requiring indwelling urinary catheters

  3. Quality of Recovery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2017
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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