Dyspepsia Clinical Trial
Official title:
A Phase II Study to Investigate 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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