Study on the Effects of Buspirone Hydrochloride for Patients with Weak or Absent Esophageal Motility

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Buspirone hydrochloride on individuals experiencing difficulties with swallowing due to weak or absent muscle movements in the esophagus, a condition known as dysphagia. The esophagus is the tube that carries food from the mouth to the stomach, and in some people, it doesn’t move food effectively, leading to swallowing problems. The study aims to understand how Buspirone hydrochloride, which is taken as a tablet, can help improve the movement of the esophagus and ease symptoms of dysphagia.

Participants in the study will receive either the Buspirone hydrochloride tablet or a placebo tablet, which looks like the medication but does not contain the active drug. The study is designed to compare the effects of the actual medication with the placebo to see if there is a significant improvement in esophageal movement and swallowing symptoms. The trial will use a special test called high-resolution esophageal manometry, which measures the pressure and movement inside the esophagus, to assess the effects of the treatment.

The study will take place over a period of time, during which participants will undergo several assessments to monitor changes in their condition. The goal is to determine if Buspirone hydrochloride can be an effective treatment for improving esophageal motility and reducing the symptoms of dysphagia. This research could potentially lead to better management options for individuals suffering from this condition.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be asked to provide consent to participate.

You will be assessed to ensure you meet the eligibility criteria, which include having symptoms of difficulty swallowing for at least two months and being over 18 years old.

2 initial assessment

An initial assessment will be conducted to evaluate your esophageal motility using a procedure called high-resolution impedance manometry. This involves measuring the movement and pressure in your esophagus while swallowing a liquid.

3 medication phase

You will be randomly assigned to receive either the active medication, buspirone hydrochloride, or a placebo. The medication is in the form of a 10 mg tablet taken orally.

The medication will be administered according to a schedule provided by the study team. You will take the tablet as directed, typically once daily, for a specified period.

4 cross-over phase

After completing the first medication phase, there will be a washout period where no medication is taken. This allows the effects of the first treatment to clear from your system.

You will then switch to the other treatment (either buspirone or placebo) and follow the same administration schedule as before.

5 follow-up assessments

Throughout the trial, follow-up assessments will be conducted to monitor changes in your symptoms and esophageal motility. These assessments will use the same high-resolution impedance manometry procedure.

You will be asked to report any changes in your symptoms using a scoring system to evaluate the passage of food through your esophagus.

6 completion of trial

At the end of the trial, a final assessment will be conducted to gather data on the effects of the treatments.

You will be provided with information about the study’s findings and any relevant health advice based on your participation.

Who Can Join the Study?

The patient must have ineffective motility or absent contractility identified on a test called HRiM, which checks how well the esophagus moves.
The patient must have a primary complaint of dysphagia, which means difficulty swallowing, for at least 2 months.
The patient must be older than 18 years.
There should be no anatomical cause for the symptoms, meaning no physical blockages or abnormalities causing the swallowing issues.
The patient should not have a hiatal hernia that is 3 cm or larger. A hiatal hernia is when part of the stomach pushes up into the chest through an opening in the diaphragm.
Sexually active women who can have children must use an appropriate form of contraception while participating in the study.

Who Cannot Join the Study?

Patients with ineffective motility or absent peristalsis cannot participate. This means if your esophagus (the tube that carries food from your mouth to your stomach) does not move food properly, you cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2019

Trial locations

Investigated drugs:

Buspirone Hydrochloride

Buspirone is a medication that is being tested in this clinical trial to see how it affects the movement of the esophagus, which is the tube that carries food from your mouth to your stomach. People with poor esophageal motility often have trouble swallowing, and this study is looking at whether buspirone can help improve the way the esophagus moves and how well it can transport food. The trial uses special tests to measure these effects, and the goal is to see if buspirone can make swallowing easier for people with this condition.

Investigated diseases:

Gastrointestinal motility disorder

Ineffective Esophageal Motility – Ineffective esophageal motility is a condition where the muscles of the esophagus do not contract properly, leading to difficulties in moving food from the throat to the stomach. This condition is characterized by weak or absent peristalsis, which is the wave-like muscle contractions that normally propel food through the esophagus. As a result, individuals may experience symptoms such as difficulty swallowing, sensation of food sticking in the chest, or regurgitation. Over time, the ineffective motility can lead to discomfort and nutritional issues due to impaired food passage. The condition is often evaluated using techniques like high-resolution manometry to assess the strength and coordination of esophageal muscle contractions.

Trial ID:

2024-516667-91-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Buspirone Hydrochloride for Patients with Weak or Absent Esophageal Motility

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?