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

Dyspepsia Clinical Trial

Official title:

A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303264
• Other study ID #: DEX-MD-20
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2006
• Last updated: March 1, 2012
• Start date: May 2006
• Est. completion date: August 2007

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• dexloxiglumide

• Nexium (esomeprazole)

Locations

Country	Name	City	State
United States	For information regarding investigative sites please contact Forest Professional Affairs	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in (upper GI) pain/discomfort intensity.
Secondary	Change from baseline in (upper GI) non-pain symptoms.