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Nexium Dyspepsia/AST

Primary Purpose

Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
November 9, 2005
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00251914
Brief Title
Nexium Dyspepsia/AST
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
Title
The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
Title
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 Measure Information:
Title
The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
Title
The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
Title
Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Santa Fe
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Argentina
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Tucumán
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Argentina
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Aalst
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Belgium
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Andenne
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Belgium
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Bonheiden
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Belgium
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Brugge
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Belgium
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Brussels (Etterbeek)
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Belgium
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Belgium
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Belgium
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Brussels (Woluwé-St-Lambert)
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Belgium
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Brussels
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Belgium
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Chimay
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Damme
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Edegem
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Liège
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Brazil
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Belo Horizonte
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Biella
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Moss
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Trondheim
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Brasov
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Bucharest
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Romania
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Tirgu Mures
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Singapore
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Singapore
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Lyttelton Manor
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South Africa
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Parktown
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South Africa
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Pretoria
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South Africa
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South Africa
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Santiago de Compostela
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A Coruña
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Spain
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Santiago
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Spain
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Viladecans
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Göteborg
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Jönköping
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Kristinehamn
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Sweden
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Lund
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Malmö
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Skövde
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Stockholm
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Sundsbruk
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Sweden
Facility Name
Research Site
City
Ängelholm
Country
Sweden
Facility Name
Research Site
City
Baden
State/Province
AG
Country
Switzerland
Facility Name
Research Site
City
Frick
State/Province
AG
Country
Switzerland
Facility Name
Research Site
City
Spreitenbach
State/Province
Zurich
Country
Switzerland
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Ennetbaden
Country
Switzerland
Facility Name
Research Site
City
Sargans
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19577008
Citation
Paggi S, Radaelli F, Amato A, Meucci G, Mandelli G, Imperiali G, Spinzi G, Terreni N, Lenoci N, Terruzzi V. The impact of narrow band imaging in screening colonoscopy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1049-54. doi: 10.1016/j.cgh.2009.06.028. Epub 2009 Jul 1.
Results Reference
derived
PubMed Identifier
17697201
Citation
Talley NJ, Vakil N, Lauritsen K, van Zanten SV, Flook N, Bolling-Sternevald E, Persson T, Bjorck E, Lind T; STARS I Study Group. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning: does a 1-week trial of acid suppression predict symptom response? Aliment Pharmacol Ther. 2007 Sep 1;26(5):673-82. doi: 10.1111/j.1365-2036.2007.03410.x.
Results Reference
derived

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Nexium Dyspepsia/AST

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