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

Primary Purpose

Functional Dyspepsia, Postprandial Fullness Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Itopride
Placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Functional Dyspepsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Itopride

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Validation of LPDS questionnaire
    Responsiveness of LPDS

    Secondary Outcome Measures

    Percentage of subject that improved after treatment with itopride based on the LPDS validated questionnaire
    Percentage of subjects that show a decrease of at least 0.5 in the LPDS score at the end of the treatment. We calculated the number of patients that reached the LPDS MCID (≥0.5) and at a higher response threshold (≥0.7) and differences between proportions were analysed with the Chi-squared test.
    Efficacy of itopride compared to baseline based on the LPDS validated questionnaire
    Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
    Efficacy of itopride compared to baseline in the dyspepsia subgroups on based on the LPDS validated questionnaire
    Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.

    Full Information

    First Posted
    November 16, 2020
    Last Updated
    November 23, 2020
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04647955
    Brief Title
    Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup
    Official Title
    Validation of a Questionnaire for Symptom Assessment in Postprandial Distress Syndrome (Functional Dyspepsia)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 22, 2013 (Actual)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Dyspepsia, Postprandial Fullness Syndrome

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Itopride
    Arm Type
    Experimental
    Arm Description
    Oral dose of itopride 100 mg three times daily before the meal for 8 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Oral dose of placebo three times daily before the meal for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Itopride
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients were treated for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Validation of LPDS questionnaire
    Description
    Responsiveness of LPDS
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of subject that improved after treatment with itopride based on the LPDS validated questionnaire
    Description
    Percentage of subjects that show a decrease of at least 0.5 in the LPDS score at the end of the treatment. We calculated the number of patients that reached the LPDS MCID (≥0.5) and at a higher response threshold (≥0.7) and differences between proportions were analysed with the Chi-squared test.
    Time Frame
    8 weeks
    Title
    Efficacy of itopride compared to baseline based on the LPDS validated questionnaire
    Description
    Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
    Time Frame
    8 weeks
    Title
    Efficacy of itopride compared to baseline in the dyspepsia subgroups on based on the LPDS validated questionnaire
    Description
    Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Tack, MD
    Organizational Affiliation
    Universitaire Ziekenhuizen KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35357058
    Citation
    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.
    Results Reference
    derived

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

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