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Naloxegol Oxalate

A clinical trial is underway to investigate the effectiveness of Naloxegol Oxalate, marketed as Moventig, in preventing opioid-induced gastrointestinal motility disturbances in patients with brain injuries. This study, known as the NIPA study, aims to evaluate how Naloxegol administration affects early constipation and ventilator-associated pneumonia in intensive care unit patients receiving opioid medications for pain management.

Table of Contents

What is Naloxegol Oxalate?

Naloxegol Oxalate, also known by its brand name Moventig, is a medication used to treat constipation caused by opioid pain medicines in adults with long-lasting pain that is not caused by cancer.[1] It comes in the form of 25 mg film-coated tablets and is taken orally.

Medical Conditions Treated

The clinical trial focuses on using Naloxegol Oxalate to treat two main medical conditions:

  • Meningeal hemorrhage: This is bleeding in the protective layers surrounding the brain and spinal cord.[1]
  • Gastrointestinal motility disorders: These are conditions that affect the movement of food through the digestive system, often leading to constipation.[1]

How Naloxegol Works

Naloxegol Oxalate belongs to a class of drugs called peripherally acting mu-opioid receptor antagonists. It works by blocking the effects of opioids specifically in the gut, which helps to relieve constipation without interfering with the pain-relieving effects of opioids in the brain.[1]

The NIPA Clinical Trial

The NIPA study (Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients) is a Phase III clinical trial designed to evaluate the effectiveness of Naloxegol in preventing constipation and other complications in patients with brain injuries who are receiving opioid medications.[1]

Main Objectives of the Trial:

  1. To evaluate the efficacy of Naloxegol in preventing early constipation (before day 6 of hospitalization).
  2. To assess its impact on the incidence of early ventilator-associated pneumonia (before day 7 of hospitalization).[1]

Secondary Objectives:

  • Assess the effect on tolerance of enteral nutrition (feeding through a tube).
  • Evaluate the time to first bowel movement in cases of late constipation.
  • Assess the need for rectal laxatives.
  • Evaluate the incidence of late-onset ventilator-associated pneumonia.
  • Assess the impact on ICU stay and neurological prognosis at 6 months.
  • Evaluate the effect on the occurrence of intracranial hypertension (high pressure inside the skull).[1]

Who Can Receive Naloxegol?

The trial has specific criteria for who can participate. Eligible patients typically include:

  • Adults admitted to the intensive care unit for head trauma or subarachnoid hemorrhage.
  • Patients receiving opioid medications for less than 24 hours.
  • Those expected to be on mechanical ventilation for at least 48 hours.
  • Patients planned for intracranial pressure monitoring and enteral feeding.[1]

However, there are several conditions that would exclude a patient from receiving Naloxegol, including severe liver disease, kidney failure, gastrointestinal obstruction, and certain other medical conditions or medications.[1]

How Naloxegol is Administered

In the clinical trial, Naloxegol is administered as follows:

  • Form: 25 mg film-coated tablets
  • Route: Taken orally
  • Maximum daily dose: 25 mg
  • Maximum total dose: 500 mg
  • Maximum treatment period: 20 days[1]

Potential Benefits of Naloxegol

The researchers hope that Naloxegol will provide several benefits for patients with brain injuries who are receiving opioid medications:

  • Prevention of constipation
  • Reduced risk of ventilator-associated pneumonia
  • Improved tolerance of enteral nutrition
  • Decreased need for additional laxatives
  • Potentially shorter ICU stays and improved neurological outcomes[1]

Precautions and Considerations

While Naloxegol may offer benefits, it’s important to be aware of potential risks and considerations:

  • It should not be used in patients with known or suspected gastrointestinal obstruction.
  • Caution is needed in patients with certain gastrointestinal conditions or recent abdominal injuries.
  • It may interact with other medications, particularly those that affect the CYP3A4 enzyme system.
  • It’s not recommended for use during pregnancy or breastfeeding.
  • Patients with severe kidney or liver problems may need dose adjustments or may not be suitable candidates for this medication.[1]
Aspect Details
Study Name The NIPA study
Drug Studied Naloxegol Oxalate (Moventig)
Main Objective Evaluate efficacy in preventing early constipation and ventilator-associated pneumonia
Patient Group Brain-injured patients receiving opioid medications in ICU
Primary Endpoints Absence of bowel movements before Day 6 and incidence of VAP before Day 7
Key Secondary Objectives Effects on enteral nutrition tolerance, time to first bowel movement, use of laxatives, late-onset VAP, and neurological prognosis
Drug Administration 25 mg film-coated tablets, oral or via feeding tube
Study Duration Up to 6 months follow-up for neurological prognosis

FAQ

  • What is the main purpose of the NIPA study? The main purpose of the NIPA study is to evaluate how effective Naloxegol is in preventing early constipation and reducing the occurrence of early ventilator-associated pneumonia in brain-injured patients who are receiving opioid medications.
  • Who can participate in this clinical trial? Participants must be admitted to the intensive care unit for head trauma or subarachnoid hemorrhage, require sedation with opioids for less than 24 hours, need invasive mechanical ventilation for at least 48 hours, and have planned intracranial pressure monitoring and enteral feeding.
  • What is Naloxegol Oxalate and how is it administered in this trial? Naloxegol Oxalate is the active ingredient in Moventig, a medication used to treat opioid-induced constipation. In this trial, it is administered as 25 mg film-coated tablets, taken orally or through a feeding tube.
  • What are some of the secondary objectives of the study? Secondary objectives include assessing the effect of Naloxegol on enteral nutrition tolerance, time to first bowel movement, use of rectal laxatives, incidence of late-onset ventilator-associated pneumonia, and neurological prognosis at 6 months.
  • Are there any specific exclusion criteria for this trial? Yes, some exclusion criteria include pregnancy, severe liver disease, certain gastrointestinal conditions, recent myocardial infarction, and use of specific medications that may interact with Naloxegol. Patients with other life-threatening injuries besides brain injury are also excluded.

Ongoing Clinical Trials on Naloxegol Oxalate

  • Study on Naloxegol to Prevent Constipation in Patients with Brain Injury and Opioid Use

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Naloxegol Oxalate: An active ingredient used in medication to treat opioid-induced constipation. It works by blocking opioids from affecting the digestive system while still allowing them to relieve pain.
  • Opioid-induced gastrointestinal motility disturbance: A side effect of opioid medications that can slow down the movement of food through the digestive system, often leading to constipation.
  • Subarachnoid hemorrhage: A type of bleeding that occurs in the space between the brain and the thin tissues that cover it, often caused by a ruptured aneurysm or head injury.
  • Ventilator-associated pneumonia (VAP): A lung infection that develops in people who are on mechanical ventilation breathing machines in hospitals.
  • Intracranial pressure monitoring: A medical procedure to measure the pressure inside the skull, which is important in managing brain injuries.
  • Enteral nutrition: A method of providing food through a tube directly into the stomach or small intestine when a person cannot eat by mouth.
  • GOSE score: Glasgow Outcome Scale Extended, a system used to assess the recovery and outcome of patients with brain injuries.
  • CYP3A4 inhibitors: Substances that block the action of an enzyme in the body that helps process certain medications, potentially affecting how other drugs work.

References

  1. http://clinicaltrials.eu/trial/study-on-naloxegol-to-prevent-constipation-in-patients-with-brain-injury-and-opioid-use/