Phase 4 N=136 Randomized Triple-blind Treatment

Ancillary Effects of Oral Naloxegol (Movantik)

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT03235739 ↗

Enrolled (actual)

136

Serious AEs

0.8%

Results posted

Sep 2023

Primary outcome: Primary: Residual Urine Volume — 62; 114; 48; 31 ml — p=0.84

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Naloxegol 25 MG (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Residual Urine Volume	62; 114; 48; 31; 32; 28	0.84
SECONDARY Side Effects of Naloxegol on Other Opioid Related Side Effects	0.53; 0.45; 0.34; 0.34	0.91
SECONDARY Need for Indwelling Urinary Catheterization	19; 7	0.012 sig
SECONDARY Quality of Recovery	119; 123	0.08

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03235739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.