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

NCT04464369 | Completed Phase 4

• 1 other identifier: S54963
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

functional dyspepsia; postprandial distress syndrome

Outcome Measures

Primary Outcomes (4)

• 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.

  8 weeks

• 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.

  8 weeks

• 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

  8 weeks

• 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

  8 weeks

Secondary Outcomes (2)

• The reliability of the LPDS instrument

  Week 8

• Validity of the LPDS instrument

  Week 8

Other Outcomes (1)

• Effiacy of itopride

  Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo t.i.d.

Drug: Placebo

Itopride

ACTIVE COMPARATOR

Itopride co 100 mg t.i.d.

Drug: itopride

Interventions

itopride DRUG

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

Also known as: Ganaton

Itopride

Placebo DRUG

placebo pills matching the look and weight of the itopride tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• \. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10) at visit 2
• \. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9) at visit 2
• \. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19) at visit 2

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 16678560 BACKGROUND

MeSH Terms

Interventions

itopride

Study Officials

• Jan Tack, M.D., Ph.D.

  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: April 8, 2016
• First Posted: July 9, 2020
• Study Start: September 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

BE (1)