Ongoing Clinical Trials for Erosive Oesophagitis
There are currently 4 clinical trials investigating treatments for erosive oesophagitis, a condition where the lining of the esophagus becomes inflamed and damaged due to stomach acid. These trials are taking place across multiple European countries and are testing various medications designed to heal and maintain healing of the esophagus in both children and adults. The studies focus on comparing new and established acid-reducing medications to determine their effectiveness and safety in managing this condition.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Germany
- Greece
- Hungary
- Italy
- Lithuania
- Poland
- Portugal
- Romania
- Slovakia
- Spain
Comparison of linaprazan glurate versus lansoprazole for healing of erosive esophagitis in adults with gastroesophageal reflux disease
This study is comparing two medications used to heal erosive esophagitis caused by gastroesophageal reflux disease. The trial is testing linaprazan glurate, a new type of acid-blocking medication, against lansoprazole, a well-established treatment. Both medications work by reducing stomach acid production, but they use different mechanisms to achieve this effect.
Who can participate: Adults between 18 and 80 years old who have confirmed erosive esophagitis can join this study. Participants must be able to undergo endoscopy procedures, provide blood samples, swallow tablets and capsules, and use electronic devices for recording their symptoms. They need to have damage to the esophagus lining confirmed by endoscopy examination that has been reviewed by independent specialists.
Who cannot participate: People with a history of stomach surgery, current or past cancer of the esophagus or stomach, active bleeding in the digestive tract, severe liver or kidney problems, or known allergies to the study medications cannot participate. Pregnant or breastfeeding women, those taking medications that might interact with the study drugs, and people currently in another clinical trial are also excluded. Additionally, those with untreated H. pylori infection, recent serious heart problems, or a history of alcohol or drug abuse within the past year cannot join.
What the study involves: Participants will be randomly assigned to receive either linaprazan glurate tablets or lansoprazole capsules for up to 8 weeks. During this time, they will need to keep a daily electronic diary to track heartburn symptoms. The study includes endoscopy examinations at the beginning, at 4 weeks, and at 8 weeks to monitor how well the esophagus is healing. The main goal is to determine whether linaprazan glurate is more effective than lansoprazole in healing the damaged esophagus lining.
Investigational drugs: Linaprazan glurate is a new medication belonging to a class called potassium-competitive acid blockers. It works by directly blocking the acid-producing pumps in the stomach, providing rapid and potent acid suppression. Lansoprazole is a well-established proton pump inhibitor that has been used for many years to treat acid-related conditions by decreasing stomach acid production.
Study on Dexlansoprazole for Treating and Maintaining Healing of Erosive Esophagitis in Children Aged 2 to 11 Years
This trial is studying dexlansoprazole, a medication designed to heal and maintain healing of erosive esophagitis in children. The study has two phases: an initial 8-week treatment phase focused on healing the esophagus, followed by a 16-week maintenance phase to keep the esophagus healthy.
Who can participate: Children aged 2 to 11 years, both boys and girls, can participate. They must have a medical history of gastroesophageal reflux disease symptoms for at least 3 months before screening. The child should have reported symptoms of pain or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days during screening, recorded in an electronic diary. There must be endoscopic evidence of erosive esophagitis confirmed by an endoscopy performed during screening or within 1 week before signing consent forms.
Who cannot participate: Children outside the age range of 2 to 11 years cannot participate. Those who do not have confirmed erosive esophagitis, cannot take the study medication as prescribed, have other medical conditions that might interfere with the study, are taking medications that might interfere with the study, have participated in another clinical trial recently, or cannot follow study procedures are excluded.
What the study involves: During the 8-week initial treatment phase, participants receive dexlansoprazole orally once a day at either 30 mg or 60 mg dosage. An endoscopy is performed at the end of this phase to check healing progress. Those who have healed enter a 16-week maintenance phase, during which they continue taking dexlansoprazole at a lower dose of either 15 mg or 30 mg once daily. Another endoscopy is conducted at the end of the maintenance phase to confirm the esophagus remains healed.
Investigational drug: Dexlansoprazole is a medication that reduces stomach acid production, helping to heal the esophagus and relieve symptoms like heartburn. The trial aims to determine both its effectiveness in healing erosive esophagitis over 8 weeks and its ability to maintain that healing over an additional 16 weeks in children.
Study on Esomeprazole Magnesium for Maintaining Healing of Erosive Esophagitis in Children Aged 1 to 11 Years
This clinical trial is testing NEXIUM, which contains esomeprazole magnesium, to see how well it maintains healing of the esophagus in young children who have already been treated for erosive esophagitis. The medication is provided as an oral suspension, which is a liquid form that is easy for children to swallow.
Who can participate: Children aged 1 to 11 years with a history of gastroesophageal reflux disease for at least 3 months can join. For the healing phase, participants must have confirmed erosive esophagitis through an endoscopy performed within one week before starting treatment. For the maintenance phase, participants must have completed the healing phase and have endoscopy-confirmed healed erosive esophagitis at the 8-week visit. Children must weigh at least 10 kg. Female patients who have started menstruating must have a negative pregnancy test and use effective birth control methods throughout the study.
Who cannot participate: Children who do not have erosive esophagitis, are outside the 1 to 11 age range, cannot follow study procedures or take the medication as required, have other medical conditions that might interfere with the study, are taking medications that might interfere with the study medication, or have had recent surgery or medical procedures that might affect study results are excluded.
What the study involves: The study begins with an 8-week healing phase where participants receive NEXIUM in the form of gastro-resistant granules for oral suspension. An endoscopy is performed at the end of this phase to verify healing. Those with healed erosive esophagitis continue to a 16-week maintenance phase, during which they continue receiving NEXIUM to maintain healing. Another endoscopy is performed at the end of the maintenance phase. Throughout the study, safety is monitored through vital signs, laboratory tests, and tracking of adverse events.
Investigational drug: NEXIUM works by reducing the amount of acid produced in the stomach, which helps heal the esophagus and prevent further damage. It is classified as a proton pump inhibitor, a well-established class of medications for treating acid-related conditions.
Study on the Effects and Safety of Pantoprazole for Children and Teens with Healed Erosive Esophagitis
This trial is investigating pantoprazole’s ability to maintain healing of erosive esophagitis in children and teenagers. The study compares two different doses of pantoprazole to determine which is more effective and safe. Some participants may receive a placebo.
Who can participate: Children and teenagers aged 1 to 17 years weighing at least 7 kg can participate. Participants must have a documented erosive lesion in the esophagus confirmed by an endoscopy. Those who have started treatment with a proton pump inhibitor to heal the lesion must continue this treatment for up to 8 weeks. Participants must be able to give informed consent or assent, complete an electronic diary and other study logs, attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures. Both males and females can join, with specific rules for females of childbearing potential.
Who cannot participate: Those with other serious health conditions that might interfere with the study, currently taking medications that could affect study results, who have had surgery on their esophagus or stomach, with a history of drug or alcohol abuse, who are pregnant or breastfeeding, have participated in another clinical trial recently, have known allergies to the study medication, or are unable to follow study procedures are excluded.
What the study involves: After enrolling, participants with confirmed erosive lesions enter a healing phase if they have not completed at least 8 weeks of healing therapy with a proton pump inhibitor. At the end of 8 weeks, a follow-up endoscopy confirms healing. Once healing is confirmed, participants enter a maintenance phase lasting up to 24 weeks, during which they take pantoprazole in capsule form. Throughout the study, health is monitored through regular physical examinations, laboratory tests, blood pressure and pulse rate assessments, and an electronic diary for recording symptoms and medication use.
Investigational drug: Pantoprazole reduces the amount of acid produced in the stomach, which helps prevent further damage to the esophagus and allows it to heal. It belongs to a class of medications called proton pump inhibitors and is taken orally in pill or liquid form.
Summary
The four ongoing clinical trials for erosive oesophagitis represent a comprehensive effort to improve treatment options for both children and adults with this condition. Three of the four trials focus specifically on pediatric populations, ranging from children as young as 1 year to teenagers up to 17 years old, highlighting the medical community’s focus on addressing this condition in younger patients.
Geographically, the trials are concentrated in European countries, with Poland hosting two studies, and Belgium hosting two studies as well. The largest trial, comparing linaprazan glurate to lansoprazole, is being conducted across six countries including Czechia, Poland, Bulgaria, Germany, Romania, and Hungary, making it the most widely distributed study.
The investigational drugs being tested fall into two main categories: established proton pump inhibitors such as lansoprazole, dexlansoprazole, esomeprazole, and pantoprazole, and newer potassium-competitive acid blockers like linaprazan glurate. All medications work by reducing stomach acid production, though they use different mechanisms. Most trials follow a similar structure with an initial healing phase followed by a maintenance phase to ensure sustained healing of the esophagus.
These studies require participants to undergo endoscopy procedures to confirm diagnosis and monitor healing progress, along with maintaining electronic diaries to track symptoms. The trials aim to provide valuable data on both the effectiveness and safety of these medications, particularly in pediatric populations where treatment options have been less extensively studied.
