NCT07826455尚未招募4 期
Diagnostic Value of Early Response to Tegoprazan in Symptomatic GERD Patients: An Exploratory Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic value of tegoprazan for GERD.
Patients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week.
Investigators will compare the short-term symptom improvement between the two groups to determine if an early response to tegoprazan can help diagnose GERD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 to 75 years who have experienced symptoms of acid regurgitation or heartburn at least twice a week starting at least 3 months prior to screening.
- •Baseline Symptom Assessment Questionnaire score of at least 6 at screening.
- •7-Day Symptom Assessment Questionnaire score of at least 4 at randomization.
排除标准
- •Known hypersensitivity to Potassium-Competitive Acid Blockers (P-CABs) or benzimidazoles.
- •Presence of gastrointestinal warning symptoms (e.g., progressive dysphagia, bleeding, unintentional weight loss within 3 months, hematemesis, anemia, hematochezia, or rectal bleeding) without a confirmed negative tumor finding on endoscopy.
- •History of or planned gastrointestinal surgery that potentially affects gastric acid secretion.
- •Diagnosed with Zollinger-Ellison syndrome or other gastric acid secretion disorders.
- •Endoscopic evidence of esophageal stricture, ulcer stenosis, esophageal varices, Barrett's esophagus (> 3 cm), eosinophilic esophagitis, gastrointestinal bleeding, active peptic ulcer, or malignant tumor.
- •Clinically significant hepatic or renal impairment (AST, ALT, ALP, GGT, total bilirubin, and creatinine greater than or equal to 2 times the upper limit of normal [ULN]) at Screening.
- •Use of any prohibited medications within the specified wash-out periods or requiring continuous use during the study:
- •Within 2 weeks prior to screening: Acid suppressants (PPIs, P-CABs).
- •Within 1 week prior to screening: Prokinetics, H2 receptor antagonists, gastric mucosal protectors, antacids, or anticholinergics.
- •During the study period (continuous use): Corticosteroids, NSAIDs, antithrombotics, anticoagulants, antipsychotics, antidepressants, or anxiolytics.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo tablet will be orally administered once daily for 7 days.
干预措施: Placebo (Drug)
Tegoprazan 50 mg
Experimental
Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
干预措施: Tegoprazan 50 mg (Drug)
结局指标
主要结局
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
时间窗: Day 7
次要结局
- Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation(Day 7)
- Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score(Day 3)
- Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation(Day 3)
- Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit(Baseline and Day 7 (End of Visit))
- Percentage of patients based on baseline Hospital Anxiety and Depression Scale (HADS) score strata, compared by GERD diagnosis(Baseline and Day 7 (End of Visit))
- Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit(Baseline and Day 7 (End of Visit))
- Change from baseline in Self-Evaluation Questionnaire for dyspepsia (SEQ-DYSPEPSIA) total score at the end of visit(Baseline and Day 7 (End of Visit))
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