Ancillary Effects of Oral Naloxegol (Movantik)

Pain, Postoperative Clinical Trial

Official title:

Ancillary Effects of Oral Naloxegol (Movantik)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235739
• Other study ID #: 17-765
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: May 23, 2022

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 23, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Naloxegol 25 MG
Oral Naloxegol 25 MG
• Placebo
matching oral placebo

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Urine Volume	Residual urine volume in the bladder as assessed by bladder scan	from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Secondary	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.	Postoperative days 1-2 or until day of discharge whichever occurs first
Secondary	Need for Indwelling Urinary Catheterization	Number of patients receiving Naloxegol requiring indwelling urinary catheters	Postoperative days 1-2 or until day of discharge whichever occurs first
Secondary	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	Postoperative Days 2 or discharge day whichever was earlier