BridgeMD
Compares treatment options for GERD (Gastroesophageal Reflux Disease)
Official title A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)
ClinicalTrials.gov ID: NCT07037875
What this study is testing
What is Linaprazan glurate 50 mg Twice Daily (BID)?
Linaprazan glurate 50 mg Twice Daily (BID) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gerd (gastroesophageal reflux disease).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate: Reduces heartburn symptoms more effectively than lansoprazole Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate) Causes any side effects during treatment Has different effects depending on how much of the drug is in the blood Works differently depending on participants' genes Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures.
- Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
- The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing...
- The participant has endoscopically confirmed EE due to GERD of LA grades A to D during the Screening Period as assessed in Central Review by an...
You likely can't join if
- Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth...
- History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological...
- History of myocardial infarction/acute coronary syndrome within 3 months prior to Screening.
- History of ventricular arrhythmia or implanted cardioverter defibrillator.
- Symptomatic congestive heart failure (New York Heart Association class 3-4).
- Family history of/diagnosis of hereditary arrhythmia syndrome.
See the full eligibility criteria
- The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures.
- Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
- The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing, electronic device [e-device] completion, etc.).
- The participant has endoscopically confirmed EE due to GERD of LA grades A to D during the Screening Period as assessed in Central Review by an Independent Review Committee (IRC).
- Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth containing drugs within 6 weeks of randomization.
- History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the...
- History of myocardial infarction/acute coronary syndrome within 3 months prior to Screening.
- History of ventricular arrhythmia or implanted cardioverter defibrillator.
- Symptomatic congestive heart failure (New York Heart Association class 3-4).
- Family history of/diagnosis of hereditary arrhythmia syndrome.
- History of adult asthma that required intensive treatment in an emergency room.
- History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years.
- Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett's esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or...
- History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism, or excretion of drugs. The Investigator is to be guided by evidence of any of the...
- Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening.
- Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
- History of treatment course with lansoprazole within 2 months prior to Screening.
- Current peptic ulcer.
- Body mass index (BMI) ≤ 18 and ≥ 40 kg/m² at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Dupnitsa, Dupnitsa, Bulgaria
- Gorna Oryahovitsa, Gorna Oryahovitsa, Bulgaria
- Sliven, Sliven, Bulgaria
- Sofia, Sofia City Province, Bulgaria
- Kyustendil, Bulgaria
- Pleven, Bulgaria
- Plovdiv, Bulgaria
- Vratsa, Bulgaria
- Brno, Brno, Czechia
- Brno, Czechia
- Olomouc, Czechia
- Pardubice, Czechia
- Prachatice, Czechia
- Zábřeh, Czechia
- Batumi, Georgia
- Kutaisi, Georgia
- Marneuli, Georgia
- Tbilisi, Georgia
- Mannheim, Baden-Wurttemberg, Germany
- Dachau, Bavaria, Germany
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dupnitsa, Dupnitsa, Bulgaria; Gorna Oryahovitsa, Gorna Oryahovitsa, Bulgaria; Sliven, Sliven, Bulgaria; Sofia, Sofia City Province, Bulgaria; Kyustendil, Bulgaria; Pleven, Bulgaria and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.