Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303264
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2006-03-14
Brief Title:
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients symptoms include acid-related conditions eg 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 PPIs 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 PPIs
The standard of care for most patients presenting with dyspeptic symptoms has been with proton pump inhibitors PPI regardless of whether or not the patients symptoms include acid-related conditions eg 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 PPIs 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 PPIs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None