The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Dyspepsia
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring functional dyspepsia, cholecystokinin, CCK, gastrointestinal, intestinal transit, GI motility, bloating, upper GI discomfort, upper GI, early satiety, nausea, belching, retching, vomiting, GERD
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Have a known hypersensitivity to dexloxiglumide, any PPI, or aluminum/magnesium-containing antacids 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.
Sites / Locations
- For information regarding investigative sites please contact Forest Professional Affairs