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Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial

Primary Purpose

Functional Dyspepsia

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

itopride

Placebo

About this trial

This is an interventional other trial for Functional Dyspepsia focused on measuring functional dyspepsia, postprandial distress syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients are eligible for randomisation if all of the following criteria are met:

At visit 1:

Patients with FD diagnosis as per Rome III classification (Negative gastroscopy valid for the last 6 months)
Patients with PDS diagnosis as per Rome III by Rome III questionnaire
Patients must provide witnessed written informed consent prior to any study procedures being performed
Patients who are HP negative provided that they where not eradicated during the last 3 months.
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
At visit 2:
Patients suffering from active PDS (Rome III) as per LPDS scoring system (See Focus Group study) during 2 weeks before randomisation

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria are met:

At visit 1:

Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
Patients with any major psychiatric disorder (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years. Patients suffering from one psychiatric trouble stabilised for six month by the administration of one drug (Not amitryptiline) are acceptable.
Females who are pregnant or lactating.
Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
Patient with predominant symptoms of GERD according to GERD questionnaire (Two "yes" answer to question 21)
Patients suffering from diabetes type 1 or type 2.
Patients taking medications for the treatment of their upper digestive symptoms: prokinetics and acid suppressants (PPIs). A wash-out is allowed if medically indicated (E.g.: lack of efficacy or side-effects). This wash-out is minimum two weeks for the patients taking PPIs*
Patients with well-known hypersensitivity to gastroprokinetic drugs.
Patients with confirmed gastro-intestinal disease.
Patients with former digestive surgery affecting the gut motility.
- Many patients take PPIs in absence of efficient treatment. In the literature, PPIs appear effective in patients suffering from substantial concomitant heartburn that is not allowed for inclusion in this study. In this context, a medically indicated wash-out and the proposal of a therapeutic alternative is appropriate.

6. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10) at visit 2

7. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9) at visit 2

8. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19) at visit 2

At visit 2:

Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10)
Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9 )
Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19)
Patients presenting predominant GERD according to GERD questionnaire (Two"yes" answer to question 21)
Patients taking prohibited medications.
Patients affected by concomitant disease responsible for digestive symptoms

Sites / Locations

University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Itopride

Arm Description

Placebo t.i.d.

Itopride co 100 mg t.i.d.

Outcomes

Primary Outcome Measures

Responsiveness of the LPDS instrument (LPDS vs. PAGI-SYM)

The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the (fullness/early satiation subscales of the) PAGI-SYM.

Responsiveness of the LPDS instrument (LPDS vs. PAGI-Qol)

The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the the PAGI-QOL.

Responsiveness of the LPDS instrument (LPDS vs. OTE)

Changes in the LPDS scores from baseline to week 2 and week 4 will be correlated with the OTE at week 2 and 4

Responsiveness of the LPDS instrument (known-groups validation)

groups of patients will be formed on the basis of changes in OSS ratings over time, and changes in LPDS scores will be compared across these groups and the significance of the difference in mean changes in LPDS will be tested using analysis of variance

Secondary Outcome Measures

The reliability of the LPDS instrument

The reliability of the LPDS instrument will be evaluated using internal consistency methods, by computing Cronbach's alpha coefficient from the correlation among the symptom items using data from different time points throughout the study. In addition, the test-retest reliability will be evaluated by correlating scores between days 1 and 4 during the run-in period.

Validity of the LPDS instrument

The construct validity of the LPDS will be tested using the logic of known-groups validity. This approach compares the mean scores from LPDS across groups known to differ on the patient's assessment of OSS and OTE. The significance of the difference in mean LPDS will be tested using analysis-of-variance methods.

Full Information

NCT ID

NCT04464369

First Posted

April 8, 2016

Last Updated

July 6, 2020

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT04464369

Brief Title

Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial

Official Title

Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in Patients Suffering From Post Prandial Distress Syndrome (Functional Dyspepsia) :

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

No instrument is available for the assessment of the symptoms in patients suffering from functional dyspepsia - postprandial distress syndrome patients - PDS. Indeed PDS is an unmet clinical need in drug development. To do so, the development of suitable endpoints for its efficacy evaluation is indicated. After interviews of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of the Leuven Postprandial Distress Scale (LPDS) questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS. A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by anchor questionnaires (PAGI-SYM, OSS, OTE) at baseline and during the study drug administration period.

Detailed Description

2.3 Study design After review of the literature, identification of the intended population (PDS patients with the lowest EPS component), it has been decided that the conceptual framework for the instrument will be based on the motility subscales of DSSI assessing the severity of the symptoms on 5 point Likert Scale (0-4; no symptom, mild, moderate, severe, very severe). After interview of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of LPDS questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS. A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by PAGI-SYM, SF-NDI, OSS, OTE at baseline and during the study drug administration period. Eligibility (2w) Randomisation Study drug administration (8w) Group 1 Placebo tid (LPDS, OTE, OSS, PAGI-SYM, SF-NDI) Eligible patients Group 2 Itopride 100 mg tid (LPDS, OTE, OSS, PAGI-SYM, SF-NDI) 4.1 Interventional study for LPDS responsiveness. This study will be a multicentre randomized multiple-assessed, placebo-controlled parallel-group study of Itopride 100 mg tid in PDS. The rationale to use Itopride is the lack of efficient treatment for FD. Itopride was extensively used in FD trials and is prescribed in clinical practice in several parts of the world. The treatment period for evaluation of LPDS responsiveness will be 8 weeks after a 2 week eligibility period. Patients will assess the severity of their symptoms using the new LPDS questionnaire adapted from the conceptual framework. This will be done through daily paper diaries. Assumingly, the diaries will include ratings of PDS symptoms, EPS symptoms, bloating, nausea and belching. In addition, patients will fill out OSS, PAGI-SYM and SF-NDI questionnaires at the end of the run-in period, and after 2, 4, 6 and 8 weeks of treatment. They will also fill out OTE after 2, 4, 6 and 8 weeks of treatment. (See these different questionnaires and the rationale to use them in annex) At the end of the study, patients will be proposed to enter an open label period of one month (Itopride 100 mg tid). This open label period is not part of the study and has been associated for the benefit of the patients. 4.2 Assessment of symptom severity Individual symptom severity (hypothesized for LPDS) will be assessed in daily diaries using a 5-point Likert scale: 0 - No symptom - Mild (Symptom is present but is not bothersome) - Moderate (Symptom is present and bothersome) - Severe (Symptom interferes with normal activity) - Very severe (Normal activity is not possible) Overall symptom severity assessment (OSS) questionnaire (with 1 week recall): What was the overall severity of your stomach symptoms during the past week? (Please select one answer) No symptoms Very mild Mild Moderate Severe Very severe Overall Treatment Evaluation (OTE) questionnaire (with 1 week recall): When thinking about the last week, how have your stomach symptoms have been (compared to your condition before you started this treatment)? (please select one answer) Extremely better Much better Somewhat better A little better About the same A little worse Somewhat worse Much worse Extremely worse PAGI-SYM and SF-NFI are more complex and described in the literature

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Dyspepsia

Keywords

functional dyspepsia, postprandial distress syndrome

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo t.i.d.

Arm Title

Itopride

Arm Type

Active Comparator

Arm Description

Itopride co 100 mg t.i.d.

Intervention Type

Drug

Intervention Name(s)

itopride

Other Intervention Name(s)

Ganaton

Intervention Description

itopride is a gastroprokinetic drug that has previously been evaluated in the treatment of functional dyspepsia and which is available in a number of countries worldwide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo pills matching the look and weight of the itopride tablets

Primary Outcome Measure Information:

Title

Responsiveness of the LPDS instrument (LPDS vs. PAGI-SYM)

Description

The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the (fullness/early satiation subscales of the) PAGI-SYM.

Time Frame

8 weeks

Title

Responsiveness of the LPDS instrument (LPDS vs. PAGI-Qol)

Description

The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the the PAGI-QOL.

Time Frame

8 weeks

Title

Responsiveness of the LPDS instrument (LPDS vs. OTE)

Description

Changes in the LPDS scores from baseline to week 2 and week 4 will be correlated with the OTE at week 2 and 4

Time Frame

8 weeks

Title

Responsiveness of the LPDS instrument (known-groups validation)

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

The reliability of the LPDS instrument

Description

Time Frame

Week 8

Title

Validity of the LPDS instrument

Description

Time Frame

Week 8

Other Pre-specified Outcome Measures:

Title

Effiacy of itopride

Description

After blinded analysis for validation of the LPDS instrument the code will be broken and efficacy of itopride versus placebo will be evaluated using the LPDS instrument.

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients are eligible for randomisation if all of the following criteria are met: At visit 1: Patients with FD diagnosis as per Rome III classification (Negative gastroscopy valid for the last 6 months) Patients with PDS diagnosis as per Rome III by Rome III questionnaire Patients must provide witnessed written informed consent prior to any study procedures being performed Patients who are HP negative provided that they where not eradicated during the last 3 months. 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 At visit 2: Patients suffering from active PDS (Rome III) as per LPDS scoring system (See Focus Group study) during 2 weeks before randomisation Exclusion Criteria: Patients are excluded from the study if any of the following criteria are met: At visit 1: Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study Patients with any major psychiatric disorder (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years. Patients suffering from one psychiatric trouble stabilised for six month by the administration of one drug (Not amitryptiline) are acceptable. Females who are pregnant or lactating. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) Patient with predominant symptoms of GERD according to GERD questionnaire (Two "yes" answer to question 21) Patients suffering from diabetes type 1 or type 2. Patients taking medications for the treatment of their upper digestive symptoms: prokinetics and acid suppressants (PPIs). A wash-out is allowed if medically indicated (E.g.: lack of efficacy or side-effects). This wash-out is minimum two weeks for the patients taking PPIs* Patients with well-known hypersensitivity to gastroprokinetic drugs. Patients with confirmed gastro-intestinal disease. Patients with former digestive surgery affecting the gut motility. Many patients take PPIs in absence of efficient treatment. In the literature, PPIs appear effective in patients suffering from substantial concomitant heartburn that is not allowed for inclusion in this study. In this context, a medically indicated wash-out and the proposal of a therapeutic alternative is appropriate. 6. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10) at visit 2 7. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9) at visit 2 8. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19) at visit 2 At visit 2: Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10) Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9 ) Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19) Patients presenting predominant GERD according to GERD questionnaire (Two"yes" answer to question 21) Patients taking prohibited medications. Patients affected by concomitant disease responsible for digestive symptoms

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Tack, M.D., Ph.D.

Organizational Affiliation

Universitaire Ziekenhuizen KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Leuven

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

16678560

Citation

Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006 Apr;130(5):1466-79. doi: 10.1053/j.gastro.2005.11.059. Erratum In: Gastroenterology. 2006 Jul;131(1):336.

Results Reference

background

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://www.targid.eu

Available IPD/Information Identifier

LPDSItopride study

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Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial

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