A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
- Be male or female, 18 to 75 years of age, inclusive.
- Must understand English and be able to follow the instructions about completing the
diary and questionnaires.
- At the time of Screening, have pain and/or discomfort in your upper abdomen for at
least one day each week in the last month.
- At the time of Screening, have at least one other symptom of FD for at least one day
each week in the last month.
- Have a known hypersensitivity to dexloxiglumide, any PPI, or
- Have a history of organic diseases, structural or biochemical, of the
gastrointestinal system that can cause dyspepsia.
- Have active irritable bowel syndrome (C-IBS, alt-IBS, D-IBS).
- Have findings leading to a clinical suspicion of other secondary causes of dyspepsia,
including endocrine, metabolic and neurological disorders.
- Have a body mass (BMI) value of greater than 38 (applies to both males and females).
- Have been enrolled in a previous investigational study of dexloxiglumide.
- Have received treatment with any investigational drug within a 30-day period, or 5
half-lives, whichever is longer, prior to study entry.
- Use or dependence on "prohibited" medications at study entry.