Nexium Dyspepsia/AST

Phase 3CompletedNCT00251914

AstraZeneca1,500 enrolled

Overview

The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,500

Conditions

Gastrointestinal Disease Signs and Symptoms, Digestive Dyspepsia

Interventions

EsomeprazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment. * Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach) Exclusion Criteria: * Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment. * Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). * Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.

Locations (215)

Outcomes

Primary Outcomes

The primary outcome is whether the patient is a responder or not after 8 weeks treatment.

The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.

The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).

Secondary Outcomes

The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,

The average symptom score and the percentage of symptom-free days during the 7-week treatment period,

Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy

Data from ClinicalTrials.gov

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Research Site

Buenos Aires, Argentina

Research Site

Mendoza, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Aalst, Belgium

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Andenne, Belgium

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Bonheiden, Belgium

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Bruges, Belgium

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Brussels, Belgium

...and 205 more locations