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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Dyspepsia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

DEX-MD-20

NCT ID:

NCT00303264

Start Date:

May 2006

Completion Date:

August 2007

Related Keywords:

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

Name

Location

For information regarding investigative sites please contact Forest Professional AffairsSt. Louis, Missouri  63045