A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
This research study is looking at a new medication called linaprazan glurate. It's being compared to a common existing treatment, lansoprazole, to see how well both medicines help people keep their healed acid reflux (erosive esophagitis) from returning. Erosive esophagitis is a condition where stomach acid has caused damage to the lining of the food pipe. The study wants to find out if the new drug is as good as, or better than, the current treatment at maintaining this healing and reducing symptoms like heartburn over several months. Participants will be adults who have already had their erosive esophagitis healed.
At a glance
What is this study about?
This study is a clinical trial that aims to find out if a new medicine, linaprazan glurate, can effectively keep the food pipe healed in people who have suffered from a condition called erosive esophagitis. Erosive esophagitis happens when acid from the stomach repeatedly comes back up into the food pipe (oesophagus), causing irritation and damage to its lining. We often call this acid reflux or GERD.
The main goal of this study is to compare how well linaprazan glurate works against a widely used medicine called lansoprazole. Lansoprazole is a type of drug that helps reduce the amount of acid your stomach makes. The researchers want to see which medicine is better at keeping the food pipe from getting damaged again over a period of 24 weeks, and then also over 52 weeks in some cases. They'll check this by looking at pictures of the inside of the food pipe (using an endoscopy).
The study also looks at how often people experience heartburn while taking these medicines. By comparing the new medicine to an established one, the researchers hope to determine if linaprazan glurate offers a valuable new option for managing erosive esophagitis and preventing it from coming back.
Key takeaways
- Tests a new acid reflux medicine (linaprazan glurate).
- Compares it to a common medicine (lansoprazole).
- Aims to keep healed food pipe damage (erosive esophagitis) from returning.
- Involves adults with a history of this condition.
- Includes check-ups, endoscopy, and symptom tracking.
- Participation lasts up to 52 weeks.
Who may be eligible?
This study is looking for adult volunteers. You must be at least 18 years old. There is no upper age limit, and both men and women can take part.
To be considered for the study, you must have been diagnosed with erosive esophagitis due to acid reflux (GERD) in the past. Importantly, your food pipe must have already healed from this damage before you can join the study. The study focuses on maintaining this healing.
Specific medical details about your past diagnosis of erosive esophagitis will be reviewed by the study team to ensure you fit the necessary criteria. Your doctor will be able to tell you if your individual health history makes you a good fit for this research.
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.
- Are you 18 years old or older?
- Have you been diagnosed with erosive esophagitis due to acid reflux (GERD) in the past?
- Has your erosive esophagitis already healed?
- Are you able to attend regular appointments for up to a year?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of several groups by chance; you won't get to choose which group you're in. This method is called 'randomised'. Neither you nor your study doctor will know which treatment you are receiving (this is called 'double-blind'). You would receive either the new drug, linaprazan glurate, or the existing drug, lansoprazole, or a placebo (a dummy pill that looks like the real thing but contains no active medicine). In some cases, because of how the study is designed, you might receive a real drug along with a placebo that looks like another drug.
You would need to attend several appointments at the study clinic over a period of up to 52 weeks (about a year). These visits would involve regular check-ups, probably blood tests, and having an endoscopy (where a tiny camera is used to look inside your food pipe) at the beginning, after 24 weeks, and potentially again after 52 weeks to see how your food pipe is healing. You would also be asked to keep track of any heartburn symptoms using an electronic diary.
Potential risks and benefits
Locations (6)
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedRomania
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedPoland
Common questions
What is erosive esophagitis?
It's a condition where stomach acid has caused damage or sores in the lining of your food pipe (oesophagus).
What is acid reflux (GERD)?
GERD stands for Gastroesophageal Reflux Disease – it's when stomach acid frequently flows back into your food pipe, causing symptoms like heartburn.
What does 'maintaining healing' mean?
It means the study is trying to see if the medicines can stop the damage to your food pipe from coming back after it has already healed.
Will I know which medicine I'm taking?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving.
How long will the study last?
Your participation could last for up to 52 weeks, which is about a year, including visits and follow-ups.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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