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Study on Glyceryl Trinitrate for Treating Esophageal Food Impaction in Adults

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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 studying a condition known as Esophageal Food Impaction, which occurs when food gets stuck in the esophagus, the tube that carries food from the mouth to the stomach. The study is testing the effectiveness of a treatment using Nitroglycerin, a medication that is commonly used to treat heart conditions by relaxing blood vessels. In this trial, nitroglycerin is being used in the form of sublingual tablets, which are small tablets placed under the tongue to dissolve.

The purpose of the study is to evaluate how well nitroglycerin works in resolving esophageal food impaction without the need for an endoscopic procedure, which is a medical technique used to remove the blockage. Participants in the study will be randomly assigned to receive either the nitroglycerin treatment or a placebo, which is a tablet that looks like the treatment but does not contain the active medication. This helps researchers compare the effects of the actual treatment against no treatment.

The study will follow participants over a period to observe the resolution of the food impaction. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the nitroglycerin or the placebo, ensuring unbiased results. The study is expected to continue until October 2025, with recruitment of participants starting in October 2023.

The research process

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

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide informed consent. This means you agree to participate after understanding the trial's purpose and procedures.
You must be at least 18 years old and have experienced esophageal food impaction for at least one hour.
Step 2
Receiving medication
You will be randomly assigned to receive either the active medication, nitroglycerin, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
The medication is provided in the form of a sublingual tablet, which means it is placed under the tongue to dissolve.
Step 3
Medication administration
You will take the sublingual tablet as directed by the trial staff. The frequency and dosage will be explained to you during the trial.
The goal is to assess if the nitroglycerin helps resolve the esophageal food impaction without needing further medical procedures.
Step 4
Monitoring and follow-up
Throughout the trial, your condition will be monitored to evaluate the effectiveness of the treatment.
You will be asked to report any changes in your condition or any side effects you experience.
Step 5
Completion of trial
The trial is expected to continue until October 2025. Your participation may end earlier if the trial objectives are met or if you choose to withdraw.
At the end of the trial, the results will be analyzed to determine the effectiveness of nitroglycerin for treating esophageal food impaction.

Who can join the trial?

3 criteria

Must be 18 years or older.
Must have symptoms that match esophageal food impaction for at least 1 hour. This means food is stuck in the esophagus, which is the tube that carries food from the mouth to the stomach.
Must provide informed consent. This means you agree to participate in the study after being told all the important details about it.

Who cannot join the trial?

9 criteria

Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are pregnant or breastfeeding are not allowed to join the study.
Patients with a history of **allergic reactions** to nitroglycerin or similar medications cannot participate. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
Patients with **severe heart problems** are excluded. Severe heart problems mean serious issues with the heart that can affect its ability to pump blood properly.
Patients who have had a **stroke** in the past 6 months cannot join. A stroke is when blood flow to a part of the brain is stopped, causing brain cells to die.
Patients with **low blood pressure** are not allowed to participate. Low blood pressure means the force of blood against your artery walls is too low, which can cause dizziness or fainting.
Patients who are currently taking medications that interact with nitroglycerin are excluded. This means if you are taking other drugs that can cause problems when used with nitroglycerin, you cannot join.
Patients with **severe liver or kidney disease** cannot participate. Severe liver or kidney disease means serious problems with these organs that affect their normal function.
Patients who have participated in another clinical trial in the last 30 days are not allowed to join.

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Verified sites

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Hillerod Hospital
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Hillerød, Denmark
Zealand University Hospital
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Koege, Denmark

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Investigated drugs

Nitroglycerin is a medication commonly used to treat chest pain or heart conditions by relaxing blood vessels and improving blood flow. In this clinical trial, nitroglycerin is being tested to see if it can help with esophageal food impaction, which is when food gets stuck in the esophagus. The goal is to determine if nitroglycerin can effectively relieve this condition by relaxing the muscles in the esophagus, allowing the food to pass more easily.

Glyceryl Trinitrate

What is already known about the treatment

Nitroglycerin – Nitroglycerin is administered as a medication to help with esophageal food impaction, which is when food gets stuck in the esophagus. It is currently being studied in a phase 2 clinical trial to determine its effectiveness for this condition. The main therapeutic use of nitroglycerin in this context is to relax the muscles of the esophagus, allowing the food to pass more easily. At the molecular level, nitroglycerin works by releasing nitric oxide, which helps to relax smooth muscles. It is classified pharmacologically as a vasodilator, which means it helps to widen blood vessels and relax muscles.

Investigated diseases

Esophageal Food Impaction – Esophageal Food Impaction occurs when food becomes lodged in the esophagus, the tube that connects the throat to the stomach. This condition can cause difficulty swallowing, chest pain, and a sensation of something being stuck in the throat. It often results from eating large pieces of food without adequate chewing or due to underlying esophageal disorders. The progression involves increasing discomfort and potential risk of esophageal damage if the obstruction is not resolved. In some cases, the impaction may lead to inflammation or infection if not addressed. The condition requires intervention to remove the blockage and prevent complications.