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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Pellegrin Hospital	Bordeaux	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cdtogr Hdqcbjwbwqj Rejtixqv Uieojvogpqted Dn Tlnsq	Tours	France
Htkdqitn Uzacxdloszqxes Septcbwnrr &xdatiu Hgqjeao dd Hynyolkifnx	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.05.2024

Trial locations

Investigated drugs:

Naloxegol Oxalate

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.

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 ID:

2024-512004-19-01

Protocol code:

2019-000959-14

NCT ID:

NCT05008926

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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