Ongoing Clinical Trials for Oesophageal Achalasia
There are currently 2 clinical trials investigating treatments for oesophageal achalasia, a condition that affects the ability of the esophagus to move food toward the stomach. These trials are taking place in France and the Netherlands, focusing on managing symptoms such as acid reflux and chest pain that can persist even after standard treatments.
Clinical trial locations
- France
- Netherlands
Study on Lansoprazole for Preventing Acid Reflux in Patients with Esophageal Achalasia After Endoscopic Myotomy
This trial, taking place in France, examines whether taking Lansoprazole regularly can prevent acid reflux after a procedure called POEM (Peroral Endoscopic Myotomy), which is used to treat achalasia. The medication comes in orodispersible tablets, meaning they dissolve in the mouth.
Who can participate: Adults aged 18 or older with all types of achalasia who have an Eckardt score greater than 3. The Eckardt score measures the severity of symptoms such as difficulty swallowing and chest pain. Participants must have an indication for the POEM procedure, provide informed consent, and be affiliated with a health insurance plan.
Who cannot participate: Patients who have not been diagnosed with achalasia or those who belong to vulnerable populations who cannot give consent for themselves cannot join this study.
What the trial involves: Participants are randomly assigned to one of two groups. The first group takes Lansoprazole 30mg daily for 12 months as routine treatment. The second group takes Lansoprazole only when symptoms of acid reflux appear. Researchers monitor participants at 6 months and 12 months to check for the presence of acid reflux using tests that measure acid exposure in the esophagus. The study also assesses esophagitis, which is inflammation of the esophagus, quality of life, and any adverse reactions.
Investigational drug: Lansoprazole is a proton pump inhibitor (PPI), which reduces the amount of acid produced in the stomach. By lowering stomach acid, it may help prevent the discomfort and potential damage caused by acid reflux after the POEM procedure.
Study of citalopram effectiveness in reducing chest pain for adults with achalasia
This trial in the Netherlands tests whether citalopram, a medication typically used for depression, can help reduce chest pain in people who have already received treatment for achalasia but still experience pain.
Who can participate: Adults aged 18 to 75 years with a confirmed diagnosis of type 1 or 2 achalasia through high-resolution manometry, a special pressure test of the esophagus. Participants must have previously undergone treatment such as balloon dilation, surgical myotomy (Heller’s myotomy), or an endoscopic procedure (POEM), with at least 3 months having passed since the last treatment. They must experience chest pain or discomfort in the middle of the chest that does not feel like burning, with at least 3 episodes per week for at least 3 months. Additional requirements include minimal food retention in the esophagus and an endoscopy within the last 5 years showing no signs of acid reflux inflammation.
Who cannot participate: People currently using medications that could interact with citalopram, those with a history of heart rhythm problems, pregnant or breastfeeding women, and individuals with major depression or other significant psychiatric disorders. Also excluded are those with known allergic reactions to citalopram, severe liver or kidney disease, recent esophageal surgery, substance abuse within the past 6 months, or severe esophageal complications.
What the trial involves: Participants receive either a 20mg citalopram tablet or a placebo tablet to take daily for 6 weeks. Neither the participant nor the doctor knows which treatment is being given during this period. Throughout the 6 weeks, participants maintain a symptom diary to record the frequency and severity of chest pain episodes. They also complete questionnaires about their general health, well-being, anxiety, and mood. After 6 weeks, doctors evaluate how much chest pain has improved. Some participants may be invited to join an optional sub-study involving additional tests to measure symptom perception and pressure sensitivity in the esophagus.
Investigational drug: Citalopram is a selective serotonin reuptake inhibitor (SSRI), typically used to treat depression and anxiety. It works by increasing serotonin levels in the brain. Researchers are investigating whether it can help reduce the frequency and intensity of chest pain in people with achalasia.
Summary
Both clinical trials address important aspects of living with achalasia beyond the initial treatment. The French trial focuses on preventing acid reflux complications after the POEM procedure, while the Dutch trial explores managing persistent chest pain that remains even after successful treatment. The use of medications already approved for other conditions, such as Lansoprazole for acid reduction and citalopram for depression, represents a practical approach to addressing these ongoing symptoms. Both studies emphasize quality of life assessment, recognizing that symptom management is crucial for patients living with this chronic condition.