Status:
COMPLETED
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Lead Sponsor:
Forest Laboratories
Conditions:
Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00303264
Start Date
May 1 2006
End Date
August 1 2007
Last Update
March 5 2012
Active Locations (1)
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1
For information regarding investigative sites please contact Forest Professional Affairs
St Louis, Missouri, United States, 63045