The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia. - Full Text View

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00303264

Purpose

"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	Intervention	Phase
Dyspepsia	Drug: dexloxiglumide Drug: Nexium (esomeprazole)	Phase II

MedlinePlus related topics: Indigestion Nausea and Vomiting

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Dexloxiglumide Cholecystokinin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change from baseline in (upper GI) pain/discomfort intensity.

Secondary Outcome Measures:

Change from baseline in (upper GI) non-pain symptoms.

Estimated Enrollment:	200
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	DEX-MD-20
Study First Received:	March 14, 2006
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00303264
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

functional dyspepsia
cholecystokinin
CCK
gastrointestinal
intestinal transit
GI motility
bloating
upper GI discomfort

upper GI
bloating
early satiety
nausea
belching
retching
vomiting
GERD

Study placed in the following topic categories:

Vomiting
Signs and Symptoms, Digestive
Cholecystokinin
Gastrointestinal Diseases
Omeprazole
Dyspepsia
Eructation

Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Nausea
Gastroenteritis
Gastritis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009