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Completed

NCT Number: NCT00303264

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

"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.

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Key information

Conditions

Dyspepsia Deglutition Disorders Digestive System Diseases Eructation Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For information regarding investigative sites please contact Forest Professional Affairs

St Louis, Missouri, 63045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexloxiglumide

Drug

Nexium (esomeprazole)

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 16, 2006
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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