A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter study to evaluate the efficacy and safety of 2 doses of linaprazan glurate compared to lansoprazole in 4 or 8 weeks healing in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
Acid reflux happens when stomach acid flows back up into the gullet (food pipe), causing heartburn. Over time, this acid can irritate and break the delicate lining of the gullet, a condition called erosive esophagitis. This clinical trial is testing a potential new treatment called linaprazan glurate to see how safe it is and how well it heals this damage. Researchers are comparing two different doses of the new medicine against lansoprazole, which is a medicine commonly prescribed by doctors today. Participants will take study tablets for up to 8 weeks. Doctors will look closely at the food pipe using a tiny camera (an endoscopy) to check whether the lining has healed. They will also track daily heartburn symptoms using a simple digital diary to see how quickly the treatments provide relief.
At a glance
What is this study about?
Many people experience acid reflux, where stomach acid rises into the food pipe and causes an uncomfortable burning feeling in the chest known as heartburn. When this happens often, the harsh stomach acid can wear away the lining of the food pipe, causing painful breaks, sores, and inflammation. In clinics, doctors grade this damage from mild to severe. Finding treatments that can quickly heal these sores and stop the pain is very important for protecting long-term gut health.
Currently, doctors often prescribe medicines called proton pump inhibitors, such as lansoprazole, to reduce stomach acid. While these help many people, they do not work completely for everyone, and severe damage can take a long time to heal. This phase 3 trial is testing a new type of acid-lowering medicine called linaprazan glurate. Researchers want to find out if it can heal the food pipe faster and more effectively than standard medicines.
Because this is a late-stage trial, researchers are gathering final evidence on how well the medicine works and checking for any side effects. By testing two doses of the new medicine against an established treatment, the study aims to give doctors and patients better options for managing painful acid reflux in the future.
Key takeaways
- The trial compares a new reflux medicine, linaprazan glurate, against the standard medicine lansoprazole.
- It aims to see if the new treatment heals damaged food pipes faster and eases daily heartburn.
- Participants take study tablets for 4 to 8 weeks and track symptoms with an electronic diary.
- Camera tests (endoscopies) are used to check the healing of the gullet lining.
- Taking part is completely voluntary and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with erosive esophagitis caused by acid reflux. This means stomach acid has caused visible sores or breaks in the lining of your food pipe, ranging from mild patches to more severe damage.
Both men and women can join. To confirm if you have this condition, doctors will need to look at your food pipe using an endoscopy before the study begins, or review a recent test you may have already had.
People with certain other stomach conditions, those who have had major gut surgery, or anyone who is pregnant or breastfeeding may not be able to take part. The study doctor will check your overall health and any other medicines you take to make sure joining the trial is safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I suffer from regular acid reflux or heartburn.
- I have been told (or suspect) I have inflammation or sores in my food pipe.
- I am willing to have camera checks (endoscopies) of my food pipe.
- I can fill in a daily digital diary about my symptoms for up to 8 weeks.
What does participation involve?
If you join, you will take part in the study for up to 8 weeks. You will be placed into a group by chance to receive either the new medicine (at one of two doses) or the standard medicine, lansoprazole. Because this is a 'dummy' study to keep things fair, you will take dummy pills alongside your active medicine so neither you nor your doctor knows which one you are receiving.
You will visit the clinic several times for health checks. Taking part involves having an endoscopy (a small camera passed gently down your throat) at the start, at 4 weeks, and potentially at 8 weeks to check how well your food pipe is healing. You will also be asked to fill in a quick electronic diary every day to record any heartburn symptoms and how severe they feel.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedCzechia
Common questions
What is an endoscopy?
An endoscopy is a common, quick procedure where a doctor passes a thin, flexible tube with a camera down your throat to look closely at the lining of your food pipe and stomach.
Will I definitely receive the new medicine?
Not necessarily. A computer randomly decides whether you receive the new medicine or the standard medicine, lansoprazole, so the comparison is completely fair.
What is a 'dummy' pill?
A dummy pill (or placebo) looks identical to the real treatment but contains no active medicine. It ensures that neither you nor the doctors know which treatment you are on, keeping the results unbiased.
How long will the study last for me?
Most participants will take the study medication for between 4 and 8 weeks, alongside a few clinic visits and daily diary entries.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the trial at any time, for any reason, without giving an explanation and without your normal medical care being affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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