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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
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

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.

Enrollment: 48
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  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

No publications provided

ClinicalTrials.gov Identifier: NCT00303264     History of Changes
Other Study ID Numbers: DEX-MD-20
Study First Received: March 14, 2006
Last Updated: March 1, 2012
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
early satiety
nausea
belching
retching
vomiting
GERD

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Omeprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013