NCT04647955

Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup

Validation of a Questionnaire for Symptom Assessment in Postprandial Distress Syndrome (Functional Dyspepsia)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. At present, no validated instrument is available for the assessment of the symptom responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have previously conducted focus group sessions and cognitive interviews in PDS patients to identify all relevant symptom items that characterize PDS. In this study we aim to validate the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its consistency, reliability and ability to detect change in the framework of a controlled treatment trial.

Conditions

• Functional Dyspepsia
• Postprandial Fullness Syndrome

Interventions

Type	Name	Description
DRUG	Itopride	Itopride is a D2 antagonist and cholinesterase inhibitor with prokinetic effects on gastric motility used to treat functional dyspepsia. Patients were treated for 8 weeks.
DRUG	Placebo	Patients were treated for 8 weeks.

Timeline

• Start date: 2013-02-22
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2020-12-01
• Last updated: 2020-12-01