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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Indigestion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

2

Esomeprazole

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Esomeprazole 40 mg QD

Interventions

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Esomeprazole

Esomeprazole 40 mg QD

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Nexium

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No