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Sponsored by: |
Forest Laboratories |
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Information provided by: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT00303264 |
"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.
Condition | Intervention | Phase |
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Dyspepsia |
Drug: dexloxiglumide Drug: Nexium (esomeprazole) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia. |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DEX-MD-20 |
Study First Received: | March 14, 2006 |
Last Updated: | August 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00303264 History of Changes |
Health Authority: | United States: Food and Drug Administration |
functional dyspepsia cholecystokinin CCK gastrointestinal intestinal transit GI motility bloating upper GI discomfort |
upper GI bloating early satiety nausea belching retching vomiting GERD |
Vomiting Signs and Symptoms, Digestive Cholecystokinin Gastrointestinal Diseases Omeprazole Dyspepsia Eructation |
Signs and Symptoms Digestive System Diseases Stomach Diseases Nausea Gastroenteritis Gastritis |
Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Gastrointestinal Diseases Gastrointestinal Agents Omeprazole Enzyme Inhibitors Dyspepsia Pharmacologic Actions |
Signs and Symptoms Digestive System Diseases Stomach Diseases Therapeutic Uses Anti-Ulcer Agents Gastroenteritis Gastritis |