Ancillary Effects of Oral Naloxegol (Movantik)

NCT03235739 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-765
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Side Effects of Naloxegol on Other Opioid Related Side Effects

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

• Need for Indwelling Urinary Catheterization

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

• Quality of Recovery

  Postoperative Days 2 or discharge day whichever was earlier

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

Drug: Naloxegol 25 MG

Placebo Arm

PLACEBO COMPARATOR

Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first

Drug: Placebo

Interventions

Naloxegol 25 MG DRUG

Oral Naloxegol 25 MG

Also known as: Movantik

Treatment Arm

Placebo DRUG

matching oral placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Alparslan Turan, MD
• Organization: Cleveland Clinic

turana@ccf.org

216-4459857

Study Officials

• Mehmet A Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 1, 2017
• Study Start: October 1, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 23, 2022
• Last Updated: September 5, 2023
• Results First Posted: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)