Postprandial Distress Itopride Cohort Trial

Официальное название

Prospective Cohort Study of Functional Dyspepsia/Postprandial Distress Syndrome Patients Treated With Itopride

Обзор

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.

Первичные конечные точки

• PAGI-SYM improvement [Срок оценки: 8 weeks]

Вторичные конечные точки (8)

• Symptom Improvement [Срок оценки: From baseline to +16 weeks (end of trial)]
• Perceived Treatment Effectiveness [Срок оценки: From baseline to +16 weeks (end of trial)]
• Health-economic evaluation: WPAI [Срок оценки: -6 months to +16 weeks (end of trial)]
• Health-economic evaluation and quality of life: EQ-5D-5L [Срок оценки: -6 months to +16 weeks (end of trial)]
• Health-economic evaluation: HRU [Срок оценки: -6 months to +16 weeks (end of trial)]
• Quality of life evaluation [Срок оценки: From baseline to +16 weeks (end of trial)]
• Treatment compliance [Срок оценки: From +8 weeks to +16 weeks (end of trial)]
• Baseline characteristics [Срок оценки: From baseline to +16 weeks (end of trial)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 1 центр

• UZ Leuven — Leuven

Идентификаторы

NCT: NCT07165301 · S70891

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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