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CompletedNCT00303264Updated Mar 5, 2012

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

A Phase 2 interventional study of dexloxiglumide and Nexium (esomeprazole) in Dyspepsia, sponsored by Forest Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by Forest Laboratories · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspepsia

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Keywords

  • functional dyspepsia
  • cholecystokinin
  • CCK
  • gastrointestinal
  • intestinal transit
  • GI motility
  • bloating
  • upper GI discomfort
  • upper GI
  • early satiety
  • nausea
  • belching
  • retching
  • vomiting
  • GERD
03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's enrollment of 48 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
48 participants (actual)

Interventions

  • Drugdexloxiglumide
  • DrugNexium (esomeprazole)
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

07

Study locations

1 site
  • For information regarding investigative sites please contact Forest Professional Affairs
    St. Louis, Missouri 63045, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00303264
Lead sponsor
Forest Laboratories
First posted
Mar 16, 2006
Start date
May 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Mar 5, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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