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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00303264
Recruitment Status : Completed
First Posted : March 16, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Dyspepsia Drug: dexloxiglumide Drug: Nexium (esomeprazole) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Study Start Date : May 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303264


Locations
United States, Missouri
For information regarding investigative sites please contact Forest Professional Affairs
St. Louis, Missouri, United States, 63045
Sponsors and Collaborators
Forest Laboratories
More Information

ClinicalTrials.gov Identifier: NCT00303264     History of Changes
Other Study ID Numbers: DEX-MD-20
First Posted: March 16, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Forest Laboratories:
functional dyspepsia
cholecystokinin
CCK
gastrointestinal
intestinal transit
GI motility
bloating
upper GI discomfort
upper GI
early satiety
nausea
belching
retching
vomiting
GERD

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action