Prospective Cohort Study of Functional Dyspepsia/Postprandial Distress Syndrome Patients Treated With Itopride
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PAGI-SYM improvement
研究概览
简要总结
Functional Dyspepsia (FD) is a common gastrointestinal disorder affecting about 7.2% of the population, characterized by gastroduodenal symptoms without an identifiable organic cause. It is divided into two subtypes based on the Rome IV criteria: (i) Postprandial Distress Syndrome (PDS): Meal-related symptoms like postprandial fullness and early satiation.; (ii) Epigastric Pain Syndrome (EPS): Meal-unrelated symptoms like epigastric pain or burning.
Treatment options are limited, but prokinetics are commonly used, targeting suspected motility issues. A meta-analysis showed prokinetics reduce symptoms. Itopride, a D2 antagonist and acetylcholinesterase inhibitor, has shown potential efficacy, especially in Asian populations.
As Itopride became available in Belgium since 2023, there is a lack of real-life outcome data in Western patients with functional dyspepsia/postprandial distress syndrome who receive treatment in standard clinical practice. Hence, the aim of this pragmatic observational study is to follow up a cohort of functional dyspepsia/postprandial distress syndrome patients in whom itopride treatment is started as part of routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with functional dyspepsia as per physician clinical criteria
- •Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose and procedures required for the study and is willing to participate in the study.
- •Patient must speak Dutch or French
排除标准
- •Patient with other clinical diagnosis than functional dyspepsia that can explain their gastrointestinal symptoms.
- •Patient has any of the following surgical history:
- •Any abdominal surgery within the 3 months prior to screening;
- •Subject has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, cholecystectomy, or polypectomy more than 3 months earlier are allowed).
- •Patient has an unstable cardiac, pulmonary, renal, hepatic, metabolic, or hematologic condition.
- •Patient has a history of active malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
- •Patient has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study.
- •In case of psychotropic drug use: patient NOT on stable doses of antidepressants (i.e., for the 3 months prior to pre-screening) will not be allowed to participate in the study. Habitual use of benzodiazepines is permitted.
- •Patient is pregnant or breastfeeding.
- •Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
结局指标
主要结局
PAGI-SYM improvement
时间窗: 8 weeks
The primary endpoint for this study is symptom improvement at week 8. For this, the symptomatic improvement as assessed by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) compared to baseline will be evaluated for each symptomatic domain (heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, lower abdominal pain) where a MCID has been previously been established.
次要结局
- Symptom Improvement(From baseline to +16 weeks (end of trial))
- Perceived Treatment Effectiveness(From baseline to +16 weeks (end of trial))
- Health-economic evaluation: WPAI(-6 months to +16 weeks (end of trial))
- Health-economic evaluation and quality of life: EQ-5D-5L(-6 months to +16 weeks (end of trial))
- Health-economic evaluation: HRU(-6 months to +16 weeks (end of trial))
- Quality of life evaluation(From baseline to +16 weeks (end of trial))
- Treatment compliance(From +8 weeks to +16 weeks (end of trial))
- Baseline characteristics(From baseline to +16 weeks (end of trial))