2024-512688-30-00招募中4 期
Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年7月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Comparison of the percentage of patients with improvement (ΔGOS ≥2) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
研究概览
简要总结
Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with symptoms of functional indigestion will be included if all of the following inclusion criteria apply:
- •Women or men aged 18-75 years old.
- •Patients that meet the Rome IV criteria of functional dyspepsia.
- •Patients with a GOS score≥
- •Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
排除标准
- •Exclusion criteria Patients will be excluded if any of the following exclusion criteria apply:
- •Pregnant and lactating women
- •Patients with symptoms of irritable bowel syndrome and gastroesophageal reflux disease.
- •Patients with suspected symptoms of severe disease (weight loss, black stools, difficulty in swallowing).
- •Abdominal surgery.
- •Unregulated diabetes.
- •Stool disorders (chronic diarrhea or constipation).
- •Active psychiatric conditions
- •Intake of immunosuppressants, antibiotics, non-steroidal, anti-inflammatory drugs or probiotics in the last 4 weeks
- •Taking oral antacid medications that act as proton pump inhibitors, prokinetic agents, histamine receptor antagonists, and laxatives during the study
- •Patients that daily use aspirin
- •Alcohol use of more than ten units (units) per week
- •Active H. pylori infection
- •Participation in another study of an investigational medicinal product or investigational medical device
结局指标
主要结局
Comparison of the percentage of patients with improvement (ΔGOS ≥2) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
Comparison of the percentage of patients with improvement (ΔGOS ≥2) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
次要结局
- Comparison of the change in severity of each symptom (VAS scale) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.
- Comparison of the percentage of patients who responded to treatment (GOS score ≤2 at visit V1) between treatment groups
- Comparison of the change in patients' quality of life based on the NDI-SF index at visit V1 versus baseline visit (V0) between the two treatment groups.
- Comparison of the percentage of patients in whom there was a decrease in GOS scale score of at least one point at visit V1 compared to the baseline visit (V0) between the two treatment groups.
- Frequency and type of adverse events during the study.
研究者
Georgios-Stefanos Soumelas
Scientific
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
研究点 (1)
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