A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Symptom Relief in Functional Dyspepsia
研究概览
简要总结
The VIVA trial is a 12-week, randomized, interventional study comparing vonoprazan monotherapy versus vonoprazan plus itopride combination therapy in adults with functional dyspepsia (FD). FD is a common digestive disorder causing upper stomach discomfort, fullness after meals, and early satiety.
The study aims to determine if adding itopride, a prokinetic that improves stomach emptying, to vonoprazan, a strong acid-suppressing drug, provides better symptom relief than vonoprazan alone. Participants will be randomly assigned to receive either treatment, and their symptoms, quality of life, and safety outcomes will be monitored throughout the study.
The trial will help guide the best management strategy for FD by targeting both acid-related and motility-related symptoms.
详细描述
Methodology
Study Design:- The design compares vonoprazan 20mg monotherapy against vonoprazan 20mg + itopride 50mg (TID) combination therapy in a 1:1 allocation ratio. The total trial duration per participant is 12 weeks, consisting of a treatment period with regular follow-up assessments. The study's schematic is as follows:
- Patients with dyspeptic symptoms will be screened for eligibility. This includes obtaining informed consent, recording medical history, confirming FD diagnosis (including verification of a normal endoscopy result and H. pylori status), and a washout from disallowed medications. Baseline symptom assessments and lab tests will be done at the end of this phase.
- Randomization (Baseline) Visit: Eligible participants are randomly assigned to one of two treatment arms (described below) after baseline evaluations. Baseline symptom scores using Post prandial distress syndrome.
- Assessment and follow up: Participants take the assigned study medications for 12 weeks. Follow-up telephone calls or visits are scheduled at regular intervals Week 4, Week 8 and physical visit at 12 weeks for monitoring and assessment.
Methodology
Study Design:- The design compares vonoprazan 20mg monotherapy against vonoprazan 20mg + itopride 50mg (TID) combination therapy in a 1:1 allocation ratio. The total trial duration per participant is 12 weeks, consisting of a treatment period with regular follow-up assessments. The study's schematic is as follows:
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days/week over the last 3 months.
- •Prior endoscopy with normal findings or minor gastritis within the last 3 months.
- •Negative Helicobacter pylori test (Rapid urease test) or urea breath test
- •The patient should be off Proton pump inhibitors for 2 weeks
排除标准
- •Evidence of structural/biochemical issues like peptic ulcer, erosive esophagitis, gastric/esophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS
- •Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility.
- •Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines).
- •Pregnancy or Lactation
- •History of Consumption of alcohol or smoking
结局指标
主要结局
Symptom Relief in Functional Dyspepsia
时间窗: 12 weeks
Proportion of participants achieving significant improvement in dyspepsia symptoms, assessed by the Leeds Dyspepsia Questionnaire (LPDS) score -The scale range from 0 to 7 7 is the highest score of anxiety/ depression, 0 is the least score.
次要结局
- Quality of Life Improvement(12 weeks)
- Responder Rate(12 weeks)
- Safety and Tolerability(12 weeks)
- Rescue Medication Use(12 weeks)
研究者
Mohan Ramchandani
Principal Investigator
Asian Institute of Gastroenterology, India