2026-525291-26-00招募中3 期
A Randomized, Multicenter, Single-Blind, Parallel-Group Phase III Non-Inferiority Trial Comparing the Efficacy and Tolerability of a Fixed-Dose Combination of Metronidazole, Bismuth Oxide and Tetracycline HCl to Standard Concomitant Non-Bismuth Quadruple Therapy for First-Line Eradication of Helicobacter pylori in Adults.
Verisfield Single Member S.A.17 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2026年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 17
- 主要终点
- The primary endpoint is the successful clearance of the infection between the two groups, established by comparing the eradication rate in the microbiological intention-to-treat (mITT) set between the treatment arms. Successful clearance is defined as a negative Urea Breath Test (UBT) following the completion of the eradication treatment.
研究概览
简要总结
The primary objective of the study is to demonstrate the non-inferiority of the fixed combination Test product compared to the standard first-line therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosed active H. pylori infection established by gastroscopy and CLO test
- •No prior treatment for H. pylori infection
- •Clear indication for eradication therapy
- •Willingness and ability to receive the study medication in the specified dose and frequency throughout the study duration.
- •Willingness to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable).
排除标准
- •Use of any of the following concomitant medications during participation in the study and within timeframes shorter than the required washout periods: a. Antibiotics: Within the previous 4 weeks. b. PPIs or PCABs: Within the previous 2 weeks. c. Bismuth Compounds: Within the previous 4 weeks.
- •Zollinger-Ellison syndrome
- •Significant organ dysfunction; severe or unstable cardiopulmonary or endocrine disease
- •Gastrointestinal bleeding or related iron-deficiency anemia (IDA); Barrett’s esophagus or high-grade dysplasia; dysphagia; idiopathic thrombocytopenic purpurea (ITP).
- •Cockayne Syndrome
- •Patients with hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval.
- •Documented or suspected atrophic gastritis, which might interfere with the urea breath test (contraindication for Helicobacter Test INFAI).
- •Any medical condition or laboratory abnormality during theScreening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's abilityto be included in the study.
- •History of substance or alcohol abuse within 1 year prior to the study.
- •Hypersensitivity to any of the active substances (metronidazole, bismuth, tetracycline, amoxicillin, clarithromycin, esomeprazole, 13C-urea), to any of the excipients, to other penicillins, macrolide antibiotics, nitroimidazole derivatives, or substituted benzimidazoles. History of a severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam agent (e.g., a cephalosporin, carbapenem, or monobactam).
- •History of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes.
- •Pregnancy or lactation
- •Use of any of the following prohibited medications during participation in the study and within timeframes shorter than the required washout periods: a) Chronic or regular use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or systemic glucocorticoids (steroids) within the past 4 weeks. b) Use of anticoagulants (e.g., warfarin, DOACs) or antiplatelet agents within the past 4 weeks, with the exception of low-dose aspirin (≤100 mg/day).
- •Use of any prohibited concomitant medication with known clinically significant or serious interactions with the study treatments, as defined in this protocol (Section 9.1), in the opinion of the Investigator.
- •Prior gastric surgery/gastrectomy or other upper gastrointestinal surgery
- •Severe comorbidity (e.g., advanced renal, hepatic, or cardiac failure) or malignancy
研究组 & 干预措施
Helicobacter Test INFAI 75 mg powder for oral solution
Auxiliary
干预措施: Helicobacter Test INFAI 75 mg powder for oral solution (Drug)
Flagyl 500 mg κάψουλες
Comparator
干预措施: Flagyl 500 mg κάψουλες (Drug)
KLARICID® 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
Comparator
干预措施: KLARICID® 500 mg επικαλυμμένα με λεπτό υμένιο δισκία (Drug)
Helides 40 mg γαστροανθεκτικά καψάκια, σκληρά
Comparator
干预措施: Helides 40 mg γαστροανθεκτικά καψάκια, σκληρά (Drug)
Amoxil 1 g διασπειρόμενα δισκία
Comparator
干预措施: Amoxil 1 g διασπειρόμενα δισκία (Drug)
Metronidazole + Bismuth oxide + Tetracycline hydrochloride / Verisfield f.c. tablet
Test
干预措施: Metronidazole + Bismuth oxide + Tetracycline hydrochloride / Verisfield f.c. tablet (Drug)
结局指标
主要结局
The primary endpoint is the successful clearance of the infection between the two groups, established by comparing the eradication rate in the microbiological intention-to-treat (mITT) set between the treatment arms. Successful clearance is defined as a negative Urea Breath Test (UBT) following the completion of the eradication treatment.
The primary endpoint is the successful clearance of the infection between the two groups, established by comparing the eradication rate in the microbiological intention-to-treat (mITT) set between the treatment arms. Successful clearance is defined as a negative Urea Breath Test (UBT) following the completion of the eradication treatment.
次要结局
- H. pylori eradication rate in the Per-Protocol (PP) population.
- Superiority: Statistical comparison of eradication rates (mITT and PP) to test for superiority of the Test arm over the Active Comparator.
- Compliance: The proportion of patients with adequate adherence (defined as consumption of ≥90% of prescribed units) based on unit counts and diary records.
- Incidence of Adverse Events (AEs): The proportion of patients reporting at least one AE.
- Tolerability: The proportion of patients who discontinued treatment prematurely due to AEs.
研究者
Clinical Department
Scientific
Verisfield Single Member S.A.
研究点 (17)
Loading locations...
相似试验
尚未招募
3 期
A phase III study to examine effectiveness, safety, pharmacokinetics, and immunogenicity of test brentuximab vedotin (ZRC-3318), administered in combination with chemotherapy, in patients with previously untreated stage III or IV classical Hodgkin lymphomaCTRI/2025/07/091606Zydus Lifesciences Limited201
已完成
3 期
A randomized, double-blind, parallel-group and active controlled clinical study to assess the efficacy and safety of FDC of Bisoprolol and Cilnidipine tablet versus FDC of Metoprolol Succinate ER and Cilnidipine in treating Hypertension associated with coronary artery diseaseCTRI/2024/11/077154Windlas Biotech Limited250
尚未招募
3 期
Treatment of Fever with Unani medicine Cap MubarakCTRI/2024/01/061859Central Council for Research in Unani Medicine CCRUM New Delhi60
尚未招募
3 期
A Phase III Study of GS101 Injection to Dupixent®NCT07386743Jiangsu Genscend Biopharmaceutical Co., Ltd572
尚未招募
3 期
To Evaluate the Effectiveness, Safety, Pharmacokinetic and Immunogenicity of Intravenous Infusion of Pembrolizumab (Sun Pharmaceutical Industries Limited) in comparison with Reference Medicinal Product (Keytruda) in treatment of Patients with Non-Squamous Metastatic Non-Small Cell Lung CarcinomaCTRI/2026/02/104111Sun Pharmaceutical Industries Limited (SPIL)237