Clinical Trial: The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.

Brief Summary:

"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.

Detailed Summary:
Sponsor: Forest Laboratories

Current Primary Outcome: Change from baseline in (upper GI) pain/discomfort intensity.

Original Primary Outcome: Change from baseline in (upper GI) pain intensity.

Current Secondary Outcome: Change from baseline in (upper GI) non-pain symptoms.

Original Secondary Outcome: Change from baseline in (upper GI) non-pain symptoms (discomfort).

Information By: Forest Laboratories

Dates:
Date Received: March 14, 2006
Date Started: May 2006
Date Completion:
Last Updated: March 1, 2012
Last Verified: March 2012