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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have experienced head trauma or a type of bleeding in the brain known as meningeal hemorrhage. These conditions can lead to problems with the movement of food through the digestive system, known as gastrointestinal motility disorders. The study is investigating the use of a medication called Moventig, which contains the active ingredient naloxegol oxalate. This medication is being tested to see if it can help prevent constipation and lung infections in patients who are receiving strong pain medications, known as opioids, while in intensive care.

The purpose of the study is to evaluate how effective naloxegol is in preventing early constipation and lung infections in patients with brain injuries who are being treated with opioids. Participants in the study will receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will follow patients to see if they experience any bowel movements or lung infections during their hospital stay.

Throughout the study, researchers will monitor various aspects of the patients' health, such as their ability to meet nutritional goals, the need for additional medications to manage vomiting or constipation, and the length of time they require mechanical ventilation. The study will also track the overall recovery of patients over a period of six months, using a scale called the Glasgow Outcome Scale Extended (GOSE), which measures recovery after brain injury. The study is expected to continue until September 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), admission to the intensive care unit for head trauma or subarachnoid hemorrhage, and planned sedation with specific medications for less than 24 hours.

    The study involves monitoring intracranial pressure and planning enteral feeding through a tube.

  2. Step 2

    Medication administration

    Participants receive either Moventig 25 mg film-coated tablets or a placebo. The medication is taken orally.

    The purpose of the medication is to prevent gastrointestinal motility disturbances caused by opioids in patients with brain injuries.

  3. Step 3

    Monitoring and evaluation

    The primary goal is to assess the effectiveness of naloxegol in preventing early constipation and ventilator-associated pneumonia.

    Monitoring includes checking for bowel movements and the incidence of pneumonia during the first week of hospitalization.

  4. Step 4

    Secondary assessments

    Secondary assessments involve evaluating nutritional intake, the need for additional medications for vomiting or constipation, and the duration of mechanical ventilation.

    Other factors include the length of stay in the intensive care unit and the patient's recovery status six months after the trial.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by September 15, 2026.

    Participants' progress and outcomes are documented throughout the study period.

Who can join the trial?

7 criteria

  • Must be **18 years or older**.
  • Admitted to the **intensive care unit** due to **head trauma** or **subarachnoid hemorrhage**. This means a serious head injury or bleeding in the space around the brain, without any other life-threatening injuries.
  • Receiving **sedation** for brain protection, using specific pain-relief medications called **morphinomimetics**. These are drugs like Sufentanil, Fentanyl, Remifentanil, or Morphine, given through a vein for less than 24 hours.
  • Expected to need a **breathing machine** and sedation for at least 48 hours.
  • Plan to monitor **intracranial pressure**, which means checking the pressure inside the skull.
  • Plan to receive **enteral feeding**, which is feeding through a tube that goes through the mouth or nose into the stomach.
  • Must be **affiliated with or benefiting from a social security scheme**.

Who cannot join the trial?

3 criteria

  • Patients with a history of head trauma cannot participate. This means any injury to the head that might have affected the brain.
  • Patients with gastrointestinal motility disorders are excluded. This refers to problems with the movement of food through the digestive system.
  • Patients who have experienced meningeal hemorrhage are not eligible. This is bleeding in the protective layers covering the brain and spinal cord.
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Investigated drugs

Naloxegol is a medication used in this trial to prevent constipation caused by opioid use in patients with brain injuries. It works by blocking the effects of opioids on the gut, helping to maintain normal bowel movements. This medication is being tested to see if it can also reduce the risk of lung infections that can occur when patients are on ventilators.

What is already known about the treatment

Naloxegol – Naloxegol is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in preventing gastrointestinal motility disturbances caused by opioids, particularly in patients with brain injuries. The main therapeutic indication for Naloxegol is to alleviate opioid-induced constipation. At the molecular level, it works by blocking opioid receptors in the gut, which helps restore normal bowel function without affecting pain relief in the brain. It is classified as a peripherally acting mu-opioid receptor antagonist.

Investigated diseases

  • Head Trauma

    Head trauma refers to any injury to the scalp, skull, or brain. It can result from falls, accidents, or blows to the head. Symptoms may include headaches, confusion, dizziness, and in severe cases, loss of consciousness. The severity can range from mild concussions to severe brain injuries. Recovery depends on the extent of the injury and can vary from a few days to longer periods. Monitoring and rest are often necessary to ensure proper healing.

  • Gastrointestinal Motility Disorders

    These disorders involve abnormal movement of the digestive tract muscles, affecting the passage of food and waste. Symptoms can include bloating, nausea, vomiting, constipation, or diarrhea. The condition can be caused by nerve or muscle problems in the gastrointestinal tract. It can affect any part of the digestive system, from the esophagus to the intestines. The progression can lead to discomfort and nutritional issues if not managed. Lifestyle changes and dietary adjustments are often recommended to alleviate symptoms.

  • Meningeal Hemorrhage

    Meningeal hemorrhage is bleeding that occurs between the layers of tissue covering the brain and spinal cord. It can result from trauma, aneurysms, or other vascular issues. Symptoms may include a sudden severe headache, neck stiffness, and sensitivity to light. The condition can lead to increased pressure on the brain, causing further complications. Immediate medical attention is crucial to manage the bleeding and prevent damage. Recovery and outcomes depend on the severity and location of the hemorrhage.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512004-19-01Protocol code2019-000959-14Estimated enrolment370 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

sourced from the EU Clinical Trials Register and site verification

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