Status:
COMPLETED
Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Indigestion
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients
Detailed Description
Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise.
- C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort.
- D. Capable of and willing to give informed consent and comply with all study requirements.
- Exclusion criteria:
- A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C. Patients requiring chronic treatment with any medication inducing GI symptoms (e.g., certain antibiotics, codeine, etc.).
- D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions. G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.
- I. History or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones).
- J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day.
- M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum).
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00222131
Start Date
October 1 2003
End Date
January 1 2008
Last Update
November 27 2019
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160