Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

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

        1. - Mild (Symptom is present but is not bothersome)

        2. - Moderate (Symptom is present and bothersome)

        3. - Severe (Symptom interferes with normal activity)

        4. - 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
    

Intervention name(s): itopride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; placebo pills matching the look and weight of the itopride tablets
Other intervention name(s): Ganaton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: functional dyspepsia; postprandial distress syndrome