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

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexloxiglumide
Nexium (esomeprazole)
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring functional dyspepsia, cholecystokinin, CCK, gastrointestinal, intestinal transit, GI motility, bloating, upper GI discomfort, upper GI, early satiety, nausea, belching, retching, vomiting, GERD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • For information regarding investigative sites please contact Forest Professional Affairs

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2006
Last Updated
March 1, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00303264
Brief Title
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Official Title
A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
functional dyspepsia, cholecystokinin, CCK, gastrointestinal, intestinal transit, GI motility, bloating, upper GI discomfort, upper GI, early satiety, nausea, belching, retching, vomiting, GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dexloxiglumide
Intervention Type
Drug
Intervention Name(s)
Nexium (esomeprazole)
Primary Outcome Measure Information:
Title
Change from baseline in (upper GI) pain/discomfort intensity.
Secondary Outcome Measure Information:
Title
Change from baseline in (upper GI) non-pain symptoms.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
For information regarding investigative sites please contact Forest Professional Affairs
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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