Nexium Dyspepsia/AST

Condition(s) targeted: Gastrointestinal Disease; Signs and Symptoms, Digestive; Dyspepsia

Intervention: Esomeprazole (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: Supportive Test for Acid-Related Symptoms (STARS I) With Esomeprazole and a Following 7-Week, Double-Blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

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 outcome:

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

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Starting date: December 2002
Last updated: November 9, 2005