Nexium Dyspepsia/AST

Phase 3

Completed

• Conditions: Gastrointestinal Disease; Signs and Symptoms, Digestive; Dyspepsia

• Registration Number: NCT00251914
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
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).
The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy
The average symptom score and the percentage of symptom-free days during the 7-week treatment period,

Trial Locations

Locations (1)

Research Site; 🇨🇭 St. Gallen, Switzerland