Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
Esomeprazole 40 mg QD
Placebo
University of Kansas Medical Center
Kansas City, Kansas, United States
Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms
Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked "Please state for each day if you have experienced pain or discomfort in the stomach." Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period.
Time frame: 8 Weeks
Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours
Time (minutes) gastric pH remained \>4.0 during 24-hours gastric pH monitoring.
Time frame: 8 Weeks
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