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

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00303264

First received: March 14, 2006

Last updated: March 1, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2006
Last Updated Date	March 1, 2012
Start Date ^ICMJE	May 2006
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 29, 2006)	Change from baseline in (upper GI) pain/discomfort intensity.
Original Primary Outcome Measures ^ICMJE (submitted: March 14, 2006)	Change from baseline in (upper GI) pain intensity.
Change History	Complete list of historical versions of study NCT00303264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 29, 2006)	Change from baseline in (upper GI) non-pain symptoms.
Original Secondary Outcome Measures ^ICMJE (submitted: March 14, 2006)	Change from baseline in (upper GI) non-pain symptoms (discomfort).
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Dyspepsia
Intervention ^ICMJE	Drug: dexloxiglumide Drug: Nexium (esomeprazole)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	August 2007
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Be male or female, 18 to 75 years of age, inclusive. Must understand English and be able to follow the instructions about completing the diary and questionnaires. At the time of Screening, have pain and/or discomfort in your upper abdomen for at least one day each week in the last month. At the time of Screening, have at least one other symptom of FD for at least one day each week in the last month. Exclusion Criteria: Have a known hypersensitivity to dexloxiglumide, any PPI, or aluminum/magnesium-containing antacids Have a history of organic diseases, structural or biochemical, of the gastrointestinal system that can cause dyspepsia. Have active irritable bowel syndrome (C-IBS, alt-IBS, D-IBS). Have findings leading to a clinical suspicion of other secondary causes of dyspepsia, including endocrine, metabolic and neurological disorders. Have a body mass (BMI) value of greater than 38 (applies to both males and females). Have been enrolled in a previous investigational study of dexloxiglumide. Have received treatment with any investigational drug within a 30-day period, or 5 half-lives, whichever is longer, prior to study entry. Use or dependence on "prohibited" medications at study entry.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00303264
Other Study ID Numbers ^ICMJE	DEX-MD-20
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Forest Laboratories
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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