Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment W… (NCT05946135) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids
South Korea42 participantsStarted 2023-11-07
Plain-language summary
* This clinical trial is conducted as a double-blind, randomized, and active drug control clinical trial. If the screening results determine that the selection/exclusion criteria are met, the clinical trial drugs are randomly assigned at a 1:1 ratio of the Pexuprazan 40 mg and the Lansoprazole 15 mg dose group and taken for 4 weeks.
* Gastritis symptoms are evaluated four weeks after baseline (Visit1) and clinical drug administration (Visit2), and if it is determined that gastritis is necessary according to the medical team's judgment due to gastrointestinal symptoms during the study participation period, endoscopy is performed to check whether gastritis occurs.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. A person who voluntarily signed a consent form
✓. Adult men and women over 20 years of age
✓. Patients who require systemic steroid treatment of at least 4 weeks of moderate dose (20 mg/day or more based on prednisolone) due to respiratory diseases during screening
✓. Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening
✓. A person who has at least one of the following risk factors for gastric ulcer during screening
✓. A person who understand and follow the guidance of the research manager according to the research plan, and who can participate whole period of clinical trial
Exclusion criteria
✕. A person who has a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drug or has a history of clinically significant hypersensitivity reaction
✕. A person who has undergone surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion inhibition surgery, and gastric mucosal resection
What they're measuring
1
Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks
✕. Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer)
✕. Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding