Functional dyspepsia, postprandial distress syndrome MedDRA version: 16.0 Level: LLT Classification code 10064536 Term: Functional dyspepsia System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Ganaton
Product Name: Itopride
Pharmaceutical Form: Tablet
INN or Proposed INN: Itopride hydrochloride
CAS Number: 122892-31-3
Other descriptive name: ITOPRIDE HYDROCHLORIDE
Concentration
Sponsors
Targid University Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see APPENDIX 1.B) 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients 5. Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements At visit 2: 6. Patients suffering from active PDS (Rome III) as per LPDS scoring system (See Focus Group study) during the 2 weeks eligibility period. Postprandial fullness and/or early satiation should be present at least 4 days during the 2 weeks eligibility period with at least moderate intensity. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: At visit 1: 1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study 2. 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. 3. Females who are pregnant or lactating. 4. Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months. 5. Patients suffering from diabetes type 1 or type 2. 6. Patients taking prohibited medication will need a wash-out period of 2 weeks before they can be screened (see 3.2.1). 7. Patients with well-known hypersensitivity to gastroprokinetic drugs. 8. Patients with confirmed gastro-intestinal disease. 9. Patients with former digestive surgery affecting the gut motility. 10. Patients affected by concomitant disease responsible for digestive symptoms 11. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) 12. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10). 13. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9). 14. Patients presenting vomiting more than one day a month 15. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19). 16. Patients presenting predominant GERD according to GERD questionnaire (> two “yes” answer to question 21).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To validate a PRO in line with the FDA guideline, according to early EMA input and with close adherence with DSSI instrument that showed responsiveness in a US phase II.;Secondary Objective: To publish the validated instrument in the international literature;Primary end point(s): The responsiveness of the new instrument in patients suffering from PDS (FD) in the context of the validation of a primary endpoint for clinical trials the efficacy evaluation of emerging therapies in PDS (FD);Timepoint(s) of evaluation of this end point: At visit 6, after 8 weeks of double-blind treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactFlorencia Carbone
UZLeuven
Outcome results
None listed