Clinical Trials

Inclusion Criteria

• Fulfills Rome III criteria for functional dyspepsia
  • Must have one or more of the following
    • Bothersome postprandial fullness
    • Early satiation
    • Epigastric pain
    • Epigastric burning AND No evidence of structural disease at upper endoscopy within last 3 months that is likely to explain the symptoms
  • These must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
• At least a moderate or severe level within the previous 3 months for two of the following eight symptoms (each symptom rated as 0: None, 1: Mild, 2: Moderate, 3: Severe)
  • Upper abdominal pain
  • Excessive belching
  • Vomiting 
  • Nausea
  • Early satiation
  • Upper abdominal bloating
  • Postprandial fullness
  • Upper abdominal discomfort
• Should be able to provide a written informed consent

Exclusion Criteria

• Currently on medication for another study or who participated in another clinical trial or study within 4 weeks before the start of this study
• Women of childbearing potential who are not using contraception and pregnant or lactating women
• Had surgery that may affect gastrointestinal motility
• Has known history of gastric bleeding, intestinal obstruction or perforation
• Has known history of celiac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or microscopic colitis
• Has had any of the diseases such as reflux esophagitis, gastroduodenal ulcer, gastric adenocarcinoma, esophageal adenocarcinoma, pancreatic disease, etc. that may be an organic cause of dyspepsia
• Has liver dysfunction (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase is at least 2.5 times higher than ULN)
• Has renal dysfunction (Serum creatinine level is at least 1.5 times higher than ULN)
• Has a serious cardiovascular (including known baseline QT prolongation defined by >450 msec) or respiratory illness
• Has a diagnosed psychotic illness, substance dependence or alcoholism
• Has been currently taking drugs that may affect gastrointestinal motility (e.g., anticholinergic, Reglan, erythromycin, azithromycin, Domperidone, etc.), Buspirone, Acotiamide, Tramadol, nonsteroidal anti-inflammatory drug, systemic corticosteroids, and antidepressants, etc. within last 2 weeks of randomization
• Medications that can affect QT within last 2 weeks of randomization
• On herbal supplements for Functional Dyspepsia within last 2 weeks of randomization
• Gastric electric stimulator in place
• On narcotics or benzodiazepines within 7 days of randomization
• Score > 12 for anxiety or depression on the Hospital Anxiety and Depression Scale (HADS)
• Vulnerable study subject