Study of Motilitone to Treat Functional Dyspepsia

This is an interventional treatment trial for Dyspepsia focused on measuring Functional Dyspepsia Read More

Inclusion Criteria:

• (1) Subject fulfilling Rome III criteria for Functional Dyspepsia: They must have one or more of the following:

  1. Bothersome postprandial fullness
  2. Early satiation
  3. Epigastric pain
  4. 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.
• (2) At least a moderate or severe level within the previous 3 months for two of the following eight symptoms: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching (each symptom rated as 0: None, 1: Mild, 2: Moderate, 3: Severe).
• (3) Subjects should be able to provide a written informed consent.

Exclusion Criteria:

• (1) Subject currently on medication for another study or who participated in another clinical trial or study within 4 weeks before the start of this study.
• (2) Women of childbearing potential who are not using contraception and pregnant or lactating women.
• (3) Subject who had surgery that may affect gastrointestinal motility.
• (4) Subject with known history of gastric bleeding, intestinal obstruction or perforation.
• (5) Subject with known history of celiac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or microscopic colitis.
• (6) Subject who 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.
• (7) Subject with liver dysfunction (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase is at least 2.5 times higher than ULN).
• (8) Subject with renal dysfunction (Serum creatinine level is at least 1.5 times higher than ULN).
• (9) Subject with a serious cardiovascular (including known baseline QT prolongation defined by >450 msec) or respiratory illness.
• (10) Subject with diagnosed psychotic illnesses, substance dependence or alcoholism.
• (11) Subject 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.
• (12) Medications that can affect QT within last 2 weeks of randomization.
• (13) Subjects on herbal supplements for Functional Dyspepsia within last 2 weeks of randomization.
• (14) Subjects with gastric electric stimulator in place.
• (15) Subjects on narcotics or benzodiazepines within 7 days of randomization.
• (16) Subjects with score > 12 for anxiety or depression on the Hospital Anxiety and Depression Scale (HADS).
• (17) Vulnerable study population