The Effect of Two Prokinetics in Patients With Functional Dyspepsia : A Prospective, Double Blinded, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in overall dyspepsia symptoms at 4 weeks after drug administration
研究概览
简要总结
This prospective, double-blinded, randomized, multicenter study will compare the efficacy and safety of two prokinetic regimens in patients with Rome IV-diagnosed functional dyspepsia. Ninety-two patients will be randomized (1:1) to receive either mosapride 5 mg + DA-9701 30 mg or mosapride 5 mg + matching placebo, three times daily before meals for 4 weeks. The primary endpoint is the proportion of overall responders ("much improved" or "very much improved" on a 7-point Likert scale) at Week 4. Secondary endpoints include overall response at Week 2, change in NDI-K symptom scores and PSQI-K sleep quality scores at Week 4, and safety assessments via laboratory tests and adverse-event monitoring.
详细描述
A four-visit schedule: screening (Visit 1), randomization (Visit 2, same day), telephone follow-up at Week 2, and on-site assessment at Week 4. Screening includes informed consent, demographics, medical history, concomitant medications, labs, Rome IV questionnaire. Randomization uses opaque sealed envelopes generated by an independent statistician. Investigational products are dispensed in a double-dummy design to maintain blinding. Treatment compliance, vital signs, AEs collected at each contact. Efficacy via Likert scale, NDI-K, PSQI-K; safety via labs and AE reporting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple: Participant, Care Provider, Investigator, Outcomes Assessor - Double-blind with placebo tablets matched to DA-9701
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥19 years of age
- •Patients diagnosed with functional dyspepsia according to the Rome IV criteria, who can be classified as having postprandial distress syndrome
- •Rome IV criteria for functional dyspepsia:
- •One or more of the following symptoms:
- •Uncomfortable postprandial fullness
- •Early satiation
- •Epigastric pain
- •Epigastric burning
- •No evidence of structural disease that could explain the symptoms
- •Symptoms must have started at least 6 months before diagnosis and been present during the last 3 months
- •No history of gastrointestinal surgery
- •No organic lesions found on upper endoscopy within the past 3 months
- •Voluntarily signed informed consent to participate in this clinical trial
排除标准
- •Patients with confirmed structural diseases on upper gastrointestinal endoscopy, such as esophageal stricture, ulcer stricture, esophagogastric varices, Barrett's esophagus, active peptic ulcer, gastrointestinal bleeding, or eosinophilic esophagitis
- •Patients who have undergone surgery involving the esophagus, stomach, or duodenum
- •Patients with abnormal values in blood chemistry tests within the past month:
- •Total bilirubin, creatinine > 1.5 times the upper limit of normal (ULN)
- •AST, ALT, alkaline phosphatase, BUN > 2 times the ULN
- •Patients with diabetic gastroparesis
- •Patients with a history of drug or alcohol abuse within the past year
- •Pregnant or breastfeeding women
- •Patients currently taking medications that may affect the evaluation of the investigational drug's efficacy (e.g., acid-suppressing agents including PPIs, prokinetics, NSAIDs, anticholinergics, corticosteroids, antidepressants, erythromycin, mirtazapine, etc.) may only participate after a minimum 2-week wash-out period
- •Any other conditions that the investigator deems make the patient unsuitable for participation in the study
研究组 & 干预措施
Experimental
Experimental: Mosapride citrate 5 mg + DA-9701 30 mg, Oral, 3 times/day, 30 min before meals for 4 weeks
干预措施: Mosapride citrate 5 mg + DA-9701 30 mg (Drug)
Placebo
Placebo Comparator: Mosapride citrate 5 mg + DA-9701 placebo, Oral, 3 times/day, 30 min before meals for 4 weeks
干预措施: Mosapride citrate 5 mg + DA-9701 30 mg placebo (Drug)
结局指标
主要结局
Change in overall dyspepsia symptoms at 4 weeks after drug administration
时间窗: at 4 weeks after drug administration
At 4 weeks after drug administration, the 7-Likert scale(Overall Treatment Evaluation, OTE, 7-Likert scale) is used to assess change. Participants who report "very much improved" or "improved" are considered to show an overall response. The proportion of participants showing an overall response is compared across treatment groups based on the total number of subjects in each group. A responder is defined as a participant who is either symptom-free, reports being "very much improved," or "improved." A response is defined as a change of 50% or more in the total symptom score. The total score is calculated by either multiplying the severity of the four main symptoms or by multiplying both severity and frequency. The total score is defined as the average of the individual functional dyspepsia (FD) symptom scores.
次要结局
- Change in overall dyspepsia symptoms at 2 weeks after drug administration(at 2 weeks after drug administration)
- Changes in dyspepsia symptom scores at 4 weeks after drug administration(at 4 weeks after drug administration)
- Changes in sleep quality index scores at 4 weeks after drug administration(at 4 weeks after drug administration)
研究者
OH JUNG HWAN
M.D., Ph.D.
Eunpyeong St. Mary's Hospital