Official Title: “Inhibition of Gastric Acid Is the Key To Satisfactory Relief of Symptoms and Restoration of the Quality of Life in Patients With Epigastric Pain Related to Non-Ulcer Dyspepsia During Therapy With Esomeprazole”

Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: January 2008

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 QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy.

Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • Esomeprazole 40 mg QD
• Other: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Active Comparator: 2
  • Esomeprazole

Primary Measures

• Dyspeptic symptoms severity will be assessed with diary cards. Quality of life will be evaluated with a new disease-specific questionnaire.
  • Time Frame: over 7 consecutive days of a 2 week run in & at the end of each tx period (4, 8, 12, 16 wks
    Safety Issue?: No

Secondary Measures

• 24 hour ph monitoring recording gastric ph during day and nighttime will be calculated. In addition, the percentage of time gastric ph remains >6.0,5,4,3,& >2.0 will be evaluated & correlated with degree of symptoms relief & QOL improvement.
  • Time Frame: over 24 hours
    Safety Issue?: No

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 PPIs or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Kansas

Overall Clinical Trial Officials and Contacts

Richard Mccallum, MD Principal Investigator University of Kansas  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00222131

Study ID Number: 8777

ClinicalTrials.gov Identifier: NCT00222131

Health Authority: United States: Institutional Review Board