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

NCT ID: NCT04647955

Last Updated: 2020-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-22
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Itopride

Oral dose of itopride 100 mg three times daily before the meal for 8 weeks

Group Type: EXPERIMENTAL

Itopride

Intervention Type: DRUG

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.

Placebo

Oral dose of placebo three times daily before the meal for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients were treated for 8 weeks.

Interventions

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.

Intervention Type: DRUG

Placebo

Patients were treated for 8 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see appendix 1B)
• Patients must provide witnessed written informed consent prior to any study procedures being performed
• Patients aged between 18 and 70 years inclusive
• Male or female patients
• Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements

Exclusion Criteria

• Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
• Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). Patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline) during the last 3 months are eligible.
• Females who are pregnant or lactating.
• Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months.
• Patients suffering from diabetes type 1 or type 2.
• Patients taking medication for functional dyspepsia will need a wash-out period of 2 weeks before they can be screened
• Patients with known hypersensitivity to gastroprokinetic drugs.
• Patients with confirmed gastro-intestinal disease.
• Patients with former digestive surgery affecting upper gut motility.
• Patients affected by concomitant disease responsible for digestive symptoms
• Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
• Patients presenting symptoms of EPS several times a week according to Rome III questionnaire
• Patients presenting daily symptoms of CIN on Rome III questionnaire
• Patients presenting vomiting more than one day a month.
• Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire
• Patients presenting predominant GERD according to GERD questionnaire

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

References

Carbone F, Vandenberghe A, Holvoet L, Piessevaux H, Arts J, Caenepeel P, Staessen D, Vergauwe P, Maldague P, De Ronde T, Wuestenberghs F, Lamy V, Lefebvre V, Latour P, Vanuytsel T, Jones M, Tack J. A double-blind randomized, multicenter, placebo-controlled study of itopride in functional dyspepsia postprandial distress syndrome. Neurogastroenterol Motil. 2022 Aug;34(8):e14337. doi: 10.1111/nmo.14337. Epub 2022 Mar 31.

Reference Type: DERIVED

PMID: 35357058 (View on PubMed)

Other Identifiers

LPDSItopride

Identifier Type: -

Identifier Source: org_study_id