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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

March 14, 2006
March 1, 2012
May 2006
August 2007   (final data collection date for primary outcome measure)
Change from baseline in (upper GI) pain/discomfort intensity.
Change from baseline in (upper GI) pain intensity.
Complete list of historical versions of study NCT00303264 on ClinicalTrials.gov Archive Site
Change from baseline in (upper GI) non-pain symptoms.
Change from baseline in (upper GI) non-pain symptoms (discomfort).
Not Provided
Not Provided
 
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dyspepsia
  • Drug: dexloxiglumide
  • Drug: Nexium (esomeprazole)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2007
August 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00303264
DEX-MD-20
Not Provided
Not Provided
Forest Laboratories
Not Provided
Not Provided
Forest Laboratories
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP