NCT07686679招募中4 期
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in GIS(Gastrointestinal Symptom Score) total scores
研究概览
简要总结
This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia
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)
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
- •Main Inclusion Criteria:
- •Men or women aged 19 to 75 years, inclusive
- •Subjects diagnosed with functional dyspepsia according to the Rome IV criteria
- •Subjects with at least three symptoms rated as moderate or severe on the Gastrointestinal Symptom Score(GIS)
- •Subjects who voluntarily signed a consent form
排除标准
- •Subjects with a history of organic diseases that could cause dyspepsia
- •Subjects with hypersensitivity to investigational drugs and similar drugs
- •Pregnant or breastfeeding women
研究组 & 干预措施
DA-9701
Experimental
administered for 4weeks(DA-9701 + DA-9701-R placebo)
干预措施: DA-9701 (Drug)
DA-9701
Experimental
administered for 4weeks(DA-9701 + DA-9701-R placebo)
干预措施: DA-9701-R Placebo (Drug)
DA-9701-R
Active Comparator
administered for 4weeks(DA-9701-R + DA-9701 placebo)
干预措施: DA-9701-R (Drug)
DA-9701-R
Active Comparator
administered for 4weeks(DA-9701-R + DA-9701 placebo)
干预措施: DA-9701 Placebo (Drug)
结局指标
主要结局
Changes in GIS(Gastrointestinal Symptom Score) total scores
时间窗: Change from baseline at 4 weeks
次要结局
- Subject's global assessment(at week 4)
- Investigator's global assessment(at week 4)
- Changes in GIS(Gastrointestinal Symptom Score) total scores(Change from baseline at 2 weeks)
- Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms(Change from baseline at 2 weeks and 4 weeks)
- Changes in NDI-K QoL(Nepean Dyspepsia Index-Korean version Quality of Life) domain scores and total scores(Change from baseline at 4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
4 期
A Randomized, Non-inferiority Trial Comparing 7-Day Versus 4-Week Esomeprazole Treatment in Patients with Unexplained DyspepsiaDyspepsia2025-524044-35-00Landspitali128
尚未招募
2 期
Treatment of prolonged indigestion with polyherbal unani formulation Qurs-e-TinkarCTRI/2025/02/080956Luqman Unani Medical College Hospital and ResearchCenter40
尚未招募
不适用
Study on the Effects of Papain and Alpha-Amylase Combination in Treating Indigestion.CTRI/2025/01/078902Biological E Limited160
尚未招募
不适用
Study on causes and symptoms of indigestion in patientsCTRI/2026/02/102951Department of medicine100
招募中
2/3 期
Homeopathic treatment of indigestion in adultsCTRI/2024/12/078301D. N. De Homoeopathic Medical College and Hospital117