The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
"Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. These symptoms may present with or without the co-existence of symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled out and the source of the pain is unknown.
The standard of care for most patients presenting with dyspeptic symptoms has been with proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some success in these patients, there is a significant population of patients whose dyspeptic symptoms are not adequately treated with PPI's alone.
The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated adequately with PPI's.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.|
- Change from baseline in (upper GI) pain/discomfort intensity.
- Change from baseline in (upper GI) non-pain symptoms.
|Study Start Date:||May 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|