A Multi-center, Randomized, Double-blind, Double-dummy Phase III Clinical Study to Evaluate the Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 561
- 试验地点
- 1
- 主要终点
- Percentage of All Participants With Successful Helicobacter Pylori (H.Pylori) Eradication
研究概览
简要总结
This study is a multicenter, randomized, double-blind, double-dummy, phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China.
Screening phase: After signing the informed consent form, subjects will be determined for Helicobacter pylori infection by 13^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 ratio to receive the tegoprazan-containing bismuth quadruple therapy (hereinafter referred to as the tegoprazan group) or esomeprazole-containing bismuth quadruple therapy (hereinafter referred to as the esomeprazole group).
Treatment phase: Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days.
Follow-up phase: Within 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13^C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who volunteer to sign the written informed consent form approved by the Ethics Committee and agree to participate in this study prior to the initiation of any study procedures.
- •Subjects who are able to understand and follow the protocol requirements and agree to participate in all the study visits.
- •Males or females ≥18 years old and ≤70 years old. 4) In the screening stage, subjects are confirmed Hp infection by 13^C-urea breath test , histology test and bacterial culture, and then the investigators judge that Hp eradication treatment is required.
- •Subjects who agree to use appropriate medical method for contraception during the course of the study (not including women in medically sterile state)
排除标准
- •Subjects received Hp eradication treatment previously. 2) Subjects who have participated in other clinical studies within 4 weeks before screening, except for the following two situations:
- •The study which the subject is participating or participated in is a non-interventional study (e.g. observational study or questionnaire survey); Subject had signed the informed consent form in that study, but withdrew from that study prior to the start of any treatment.
- •Subjects who have participated in the [NC821604] study and have demonstrated ulcer healing may participate in this study.
- •Subjects who participated in the planning and execution of this study. 4) Women who are pregnant or breastfeeding. 5) Subjects with known allergy to tegoprazan, esomeprazole, penicillins or other β-lactams, macrolide antibiotics or bismuth (including any related excipients). If a skin sensitivity test (skin test) is required, it should be carried out at Visit 1 according to routine medical practice.
- •Subjects with a history of drug (including but not limited to opioids) abuse or alcohol abuse within 1 year before the screening visit.
- •Subjects with Zollinger-Ellison syndrome. 8) Subjects who have previously undergone surgery or operations that may affect gastric acid secretion or drug absorption, 9) Subjects with "warning" symptoms such as painful swallowing, severe dysphagia, bleeding, weight loss, anemia, or blood in the stool that may indicate malignant lesions of the gastrointestinal tract, unless the possibility of malignant lesions is ruled out by endoscopy.
- •Subjects with a history of malignant tumor within 5 years before screening 11) Subjects who cannot undergo upper gastrointestinal endoscopy. 12) Subjects whose upper gastrointestinal endoscopy demonstrates acute upper gastrointestinal bleeding, active gastric ulcer or duodenal ulcer, acute gastric mucosal injury or duodenal mucosal injury.
- •Subjects with uncontrolled and unstable hepatic, renal, cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, central nervous system or mental diseases as judged by investigators, in which participation in the study may affect the interpretation of their safety or research results.
- •Subjects who plan to be hospitalized for surgical treatment during the study.
- •Subjects who have taken H2 receptor antagonists or PPI within 14 days before the 13C-urea breath test during the screening period, or those who have taken antibacterial drugs, bismuth and certain Chinese medicines with antibacterial effects within 28 days before the 13C-urea breath test during the screening period.
- •Subjects who need to use the prohibited drugs listed in the protocol. 17) Subjects with any of the following laboratory test abnormalities at screening:
- •AST > upper limit of normal (ULN);
- •ALT > ULN;
- •Total bilirubin > 1.2 × ULN;
- •Creatinine > 1.5 × ULN; 18) Subjects with clinically significant electrocardiogram (ECG) abnormalities at the screening as judged by investigators.
- •Human immunodeficiency virus (HIV) antibody positive, hepatitis B virus (HBV) surface antigen positive or hepatitis C virus (HCV) antibody positive confirmed by tests.
- •Judged by the investigator, there are other conditions compromising the subject's eligibility for this study.
研究组 & 干预措施
tegoprazan
Participants will receive Tegoprazan tablets Esomeprazole magnesium enteric-coated tablets placebo Bismuth potassium citrate capsules Amoxicillin capsules Clarithromycin tablets
干预措施: Tegoprazan (Drug)
Esomeprazole
Participants will receive Tegoprazan tablets placebo Esomeprazole magnesium enteric-coated tablets Bismuth potassium citrate capsules Amoxicillin capsules Clarithromycin tablets
干预措施: Tegoprazan (Drug)
结局指标
主要结局
Percentage of All Participants With Successful Helicobacter Pylori (H.Pylori) Eradication
时间窗: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)
Percentage of all patients with Hp eradication determined by a 13\^C-urea breath test after study treatment.
次要结局
- Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline(Day 29+7 days following the completion of treatment( duration of treatment was 2 weeks))
- Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-sensitive Strain of H Pylori at Baseline(Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks))
- Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-resistant Strain of H Pylori at Baseline(Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks))
- Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-sensitive Strain of H Pylori at Baseline(Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks))