functional dyspepsia - postprandial distress syndrome MedDRA version: 18.0 Level: LLT Classification code 10064536 Term: Functional dyspepsia System Organ Class: 100000004856
Conditions
Interventions
Product Name: Rikkunshito
Product Code: TJ-43
Pharmaceutical Form: Powder for oral solution in sachet
Pharmaceutical form of the placebo: Powder for oral solution in sachet
Route of administration of
Sponsors
uzleuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At visit 1(Diagnosis before assessment of the activity of the disease by LPDS): 1. Patients with FD diagnosis as per Rome III 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 75 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 (Evaluation of the activity of the disease by LPDS before randomisation): 6. Patients suffering from active PDS (Rome III) as per LPDS scoring system during the 2 weeks eligibility period. At least moderate Postprandial fullness and/or early satiation should be present at least 4 days during the 2 weeks eligibility period. 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 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). However, patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline and mirtazapin which are forbidden) during the last 3 months are eligible. 3. Females who are pregnant or lactating. Females who refuse to take appropriate contraception at the time of informed consent. 4. Men who want to donate sperm during the study and during the 4 weeks after stopping Rikkunshito. 5. Patients who received treatment for HP eradication during the last 3 months. Patients who are HP positive may enter the study provided that their endoscopy is negative. HP status will be taken at visit 1. 6. Patients suffering from diabetes type 1 or type 2. 7. Patients taking drugs affecting the gut secretion, mucosal integrity (NSAIDs with an exception for aspirin at cardioprotective dose of max 125 mg daily), motility, and/or sensitivity. Patients taking PPIs are eligible provided that FD is predominant and heartburn limited to maximum two episodes of mild intensity per week. 8. Patients with coronary heart disease, arrhythmias or taking concomitant drugs capable to prolong the QT. 9. Patients taking concomitant drugs able to induce drug-drug interaction (P450). 10. Patients with a significant renal [serum creatinine >2 x upper limit of normal (ULN)], hepatic [alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyltransferase (GGT), bilirubin >2 x ULN], cardiovascular, pulmonary, endocrine, metabolic or haematological condition. 11. Patients with known hypersensitivity to the Ginseng or Ginger. 12. Patients with confirmed gastro-intestinal disease. 13. Patients with former digestive surgery affecting upper gut motility. 14. Patients affected by concomitant extra-digestive disease responsible for digestive symptoms. 15. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS). 16. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 or higher on question 10). 17. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 or higher on question 9). 18. Patients presenting vomiting more than one day a month. 19. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19). 20. Patients presenting predominant GERD (3 “yes” by GERD questionnaire). 21. Patients not willing to take UV protective measures or patients at increased risk for phototoxicity (use of drugs like tetracyclins, amiodarone, sulphonamides, quinolones).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the effect of Rikkunshito on gastric accommodation in patients with functional dyspepsia, measured by evaluating the IGP during intragastric nutrient infusion;Secondary Objective: to explore the changes in FD symptom severity using the Leuven Postprandial Distress Scale (LPDS).;Primary end point(s): Time to maximal satiation or score maximally on one of the epigastric symptoms and drop in intragastric pressure during nutrient administration.;Timepoint(s) of evaluation of this end point: Visit 3 and Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in dyspeptic symptoms as assessed by Dyspepsia Symptom Severity Scale (DSS), the Visceral Sensitivity Index (VSI), the Nepean Dyspepsia Index (NDI) and the PAGI-SYM;Timepoint(s) of evaluation of this end point: Visit 2, 3, 4 and 5 | — |
Countries
Belgium
Contacts
Public ContactLieselot Holvoet
UZLeuven
Outcome results
None listed