Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Compared Treatment-related adverse events
研究概览
简要总结
In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole.
详细描述
160 patients with a diagnosis of H.P. infection with indication for treatment in accordance with the IV Mexican Consensus on Helicobacter Pylori, evaluated in the Gastroenterology outpatient clinic, will be recruited. Participants will be randomized into two groups, one group will receive tegoprazan 50 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days and the second group will receive esomeprazole 40 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days. Through complementary studies, telephone calls and application of questionnaires, adherence to treatment will be evaluated and adverse events will be monitored, and once the treatment period is completed, a breath test will be performed between days 28-42 to verify eradication, thereby evaluating effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First-degree relatives with a history of gastric cancer.
- •Clinical diagnosis of uninvestigated dyspepsia in patients under 50 years of age.
- •Diagnosis of Gastric Mucosa - Aassociated Lymphoid Tissue (MALT) Lymphoma.
- •Iron deficiency anemia.
- •Unexplained thrombocytopenic purpura.
排除标准
- •Patients who have social coverage.
- •Previous eradication treatment for Helicobacter Pylori.
- •Acute upper gastrointestinal bleeding and active gastric and/or duodenal ulcer.
- •History of surgery that affects gastric acid secretion (vagotomy, gastrointestinal resection).
- •Disorders of gastric acid hypersecretion (Zollinger-Ellison Syndrome).
- •Any serious hematological, cardiovascular, neurological, nephro-urological, hepatic and pulmonary disorders.
- •Pregnancy or lactation.
- •Allergy to any of the study medications.
研究组 & 干预措施
Tegoprazan Group
Tegoprazan 50 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days
干预措施: Tegoprazan (Drug)
Esomeprazole Group
Esomeprazole 40 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
Compared Treatment-related adverse events
时间窗: Two months
Treatment-related adverse events will be evaluated by complementary serum studies and interrogated according to system organ classes and preferred terms using MedDRA. Adverse events related to the treatment of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.
Response to treatment by determining the eradication rate
时间窗: Two months
The eradication rate will be measured by a carbon-13 urea breath test that will verify the eradication of Helicobacter pylori. The eradication rate of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.
次要结局
- Report all Treatment-related adverse events(Two months)
- Percentage of patients with adherence to treatment(Two weeks)
- Brief Medication Questionnaire(Two weeks)
研究者
Yoali Maribel Velasco Santiago
Doctor assigned to gastroenterology
Hospital General de México Dr. Eduardo Liceaga