None listed
Conditions
Interventions
Drug : All 108 participants received either prokinetics plus antidepressant (placebo) (n=54, group 1) or antidepressant plus prokinetics (placebo) (n=54, group 2) treatment for 4 week
Sponsors
The Catholic University of Daegu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male and female patients > 19 years of age 2) patients with FD was defined by Rome IV criteria 3) patients with one or more symptoms of epigastric pain or soreness, postprandial fullness, or early satiation 4) no organic lesion detected by endoscopic examination withine 3 months 5) Wrritten informed consent was obtained from all participants
Exclusion criteria
Exclusion criteria: 1) Patients with allergic disease or hypersensitivity for clinical trial medication or similar drug 2) previous major abdominal surgery (except appendectomy and hysterectomy) 3) patients who had an active or healing stage peptic ulcer in the last 6 months, histories of stomach cancer, esophageal cancer, pancreatitis, pancreatic cancer, inflammatory bowel disease 4) Diabetic gastroparesis 5) patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose absorption disorders 6) Glaucoma patients, a history of myocardial infarction within 3 months, patients with moderate conduction disorders (arrhythmia, cardiac block, angular block, atrioventricular block 3 degrees), patients with severe urinary tract (prostate disease, etc.), patients with acute delirium, pyloric stenosis, paralytic ileus 7) Symptoms of reflux esophagitis and irritable bowel syndrome are worse than those of dyspepsia 8) Patients with liver dysfunction (AST, ALT> 3 times normal upper limit) or cirrhosis 9) Patients with chronic renal failure with creatinine more than twice the normal upper limit or with Clcr <30 mL / min 10) Patients with severe systemic disorders of the heart, lungs, blood and endocrine system 11) Mental neuropathy patients (manic patients, etc.), alcoholics, drug dependence (central nervous system inhibitors, etc.) 12) Patients taking drugs that may affect the efficacy of the study drug (gastrointestinal motility inhibitors, acid secretion inhibitors, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, anticholinergic agents, erythromycin, corticosteroids, and antidepressants) Subjects taking the drug may participate after a wash-out period of at least 1 week) 13) who is being pregnant or lactating 14) patients who had taken other investigational products within 1 month of the study 15) If the researcher judges that he / she is not suitable for participation other than the above items.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject global assessment by using 5-Likert scale and Binary outcome methods | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall improvement of symptom of dyspepsia at 2nd week;Individual symptom score of functional dyspepsia at week 4 relative to baseline;Changes in Anxiety Depression Index (HADS) at Week 4 versus Baseline;Changes in Quality of Life (NDI-K) scores related to dyspepsia at baseline 4;Changes in the total number of remedies taken and weekly remedies by week | — |
Countries
Korea, Republic of
Contacts
Public ContactJung Hwan Oh
The Catholic University of Korea
Outcome results
None listed