Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients

Condition(s) targeted: Indigestion

Intervention: Esomeprazole (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: University of Kansas

Official(s) and/or principal investigator(s):
Richard Mccallum, MD, Principal Investigator, Affiliation: University of Kansas
Jerzy Sarosiek, PhD, Principal Investigator, Affiliation: University of Kansas

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

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

Study design: Other, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: Dyspeptic symptoms severity will be assessed with diary cards over 7 consecutive days of a 2 week run in & at the end of each tx period (4, 8, 12, 16 wks). Quality of life will be evaluated with a new disease-specific questionnaire.

Secondary outcome: 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.

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 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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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).

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

Starting date: October 2003
Ending date: August 2007
Last updated: August 15, 2007