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

NCT04647955 | Completed Phase 4

• 1 other identifier: LPDSItopride
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Validation of LPDS questionnaire

  Responsiveness of LPDS

  8 weeks

Secondary Outcomes (3)

• Percentage of subject that improved after treatment with itopride based on the LPDS validated questionnaire

  8 weeks

• Efficacy of itopride compared to baseline based on the LPDS validated questionnaire

  8 weeks

• Efficacy of itopride compared to baseline in the dyspepsia subgroups on based on the LPDS validated questionnaire

  8 weeks

Study Arms (2)

Itopride

EXPERIMENTAL

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

Drug: Itopride

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Itopride 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.

Itopride

Placebo DRUG

Patients were treated for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• 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.

  PMID: 35357058 DERIVED

MeSH Terms

Interventions

itopride

Study Officials

• Jan Tack, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 1, 2020
• Study Start: February 22, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share