Clinical trial NCT00251914: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Disease
Signs and Symptoms, Digestive
Dyspepsia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
measure: The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
measure: 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:
measure: The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
measure: The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
measure: Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Tucumán
country: Argentina
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Andenne
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels (Etterbeek)
country: Belgium
facility: Research Site
city: Brussels (Jette)
country: Belgium
facility: Research Site
city: Brussels (Laeken)
country: Belgium
facility: Research Site
city: Brussels (Woluwé-St-Lambert)
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Chimay
country: Belgium
facility: Research Site
city: Damme
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Eupen
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Godinne
country: Belgium
facility: Research Site
city: Haine-Saint-Paul
country: Belgium
facility: Research Site
city: Kortenberg
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Sijsele
country: Belgium
facility: Research Site
city: Soignies
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Wetteren
country: Belgium
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city: Yvoir
country: Belgium
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Blumenau
country: Brazil
facility: Research Site
city: Botucatu
country: Brazil
facility: Research Site
city: Campinas
country: Brazil
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city: Florianópolis
country: Brazil
facility: Research Site
city: Pelotas
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Coquitlam
country: Canada
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state: British Columbia
city: Langley
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Conception Bay South
country: Canada
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state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
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state: Newfoundland and Labrador
city: St. John's
country: Canada
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state: Newfoundland and Labrador
city: Halifax
country: Canada
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state: Nova Scotia
city: Brampton
country: Canada
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state: Ontario
city: Courtice
country: Canada
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state: Ontario
city: Etobicoke
country: Canada
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state: Ontario
city: Hamilton
country: Canada
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state: Ontario
city: Mississauga
country: Canada
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state: Ontario
city: North York
country: Canada
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state: Ontario
city: Oshawa
country: Canada
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state: Ontario
city: Richmond Hill
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Windsor
country: Canada
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state: Ontario
city: Charlottetown
country: Canada
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state: Prince Edward Island
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: Saint-Leonard
country: Canada
facility: Research Site
state: Quebec
city: Aalborg
country: Denmark
facility: Research Site
city: Birkerød
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
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city: Herning
country: Denmark
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city: Holbæk
country: Denmark
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city: København K
country: Denmark
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city: Odense C
country: Denmark
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city: Viborg
country: Denmark
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city: Århus
country: Denmark
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city: Ales
country: France
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city: Angers
country: France
facility: Research Site
city: Belfort
country: France
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city: BOIS GUILLAUME Cedex
country: France
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city: Cannes La Bocca
country: France
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city: Charenton Le Pont
country: France
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city: Clermont Ferrand
country: France
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city: Creteil
country: France
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city: Dreux
country: France
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city: Epernay
country: France
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country: France
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city: Issoire
country: France
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city: Langon
country: France
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city: Lille
country: France
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city: MONTELIMAR Cedex
country: France
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city: Montelimar
country: France
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city: Nantes
country: France
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city: Narbonne
country: France
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city: Paris
country: France
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city: Rennes
country: France
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city: Saint Denis
country: France
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city: Saint Priest
country: France
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city: Talence
country: France
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city: Vitry Sur Seine
country: France
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
state: Brandenburg
city: Saarbrücken
country: Germany
facility: Research Site
state: Saarland
city: Halle
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
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state: Sachsen
city: Berlin
country: Germany
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city: Biederitz
country: Germany
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city: Leipzig
country: Germany
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city: Magdeburg
country: Germany
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city: Mandelbachtal-Ommersheim
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Athens
country: Greece
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city: Piraeus
country: Greece
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city: Thessaloniki
country: Greece
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city: Hafnarfjördur
country: Iceland
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city: Reykjavik
country: Iceland
facility: Research Site
city: San Benedetto Del Tronto
country: Italy
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state: AP
city: L'Aquila
country: Italy
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state: AQ
city: Biella
country: Italy
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city: Brescia
country: Italy
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city: San Cataldo
country: Italy
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state: CL
city: Como
country: Italy
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city: Cremona
country: Italy
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state: CR
city: Catania
country: Italy
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state: CT
city: Milano
country: Italy
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state: MI
city: Pisa
country: Italy
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state: PI
city: Reggio Calabria
country: Italy
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state: RC
city: Sondalo
country: Italy
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state: SO
city: Sondrio
country: Italy
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state: SO
city: Torino
country: Italy
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state: TO
city: San Daniele Del Friuli
country: Italy
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state: UD
city: Udine
country: Italy
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state: UD
city: Bologna
country: Italy
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city: Castellammare Di Stabia
country: Italy
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city: Roma
country: Italy
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city: Torre Del Greco
country: Italy
facility: Research Site
city: Aksdal
country: Norway
facility: Research Site
city: Arendal
country: Norway
facility: Research Site
city: Bergen
country: Norway
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city: Brumunddal
country: Norway
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city: Bøverbru
country: Norway
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city: Eidehavn
country: Norway
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city: Elverum
country: Norway
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city: Fevik
country: Norway
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city: Fitjar
country: Norway
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city: Flatåsen
country: Norway
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city: Fredrikstad
country: Norway
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country: Norway
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city: Hafrsfjord
country: Norway
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city: Hafslundsøy
country: Norway
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country: Norway
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city: Heimdal
country: Norway
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country: Norway
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city: Kokstad
country: Norway
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country: Norway
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city: Larvik
country: Norway
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country: Norway
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city: Løvenstad
country: Norway
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city: Moss
country: Norway
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city: Oslo
country: Norway
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city: Paradis
country: Norway
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city: Rasta
country: Norway
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city: Rolvsøy
country: Norway
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city: Ski
country: Norway
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city: Sogndal
country: Norway
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city: Spydeberg
country: Norway
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city: Stjørdal
country: Norway
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country: Norway
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city: Sørumsand
country: Norway
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city: Trondheim
country: Norway
facility: Research Site
city: Brasov
country: Romania
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city: Bucharest
country: Romania
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city: Bucuresti
country: Romania
facility: Research Site
city: Tg. Mures
country: Romania
facility: Research Site
city: Tirgu Mures
country: Romania
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
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city: Johannesburg
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Tygerberg
country: South Africa
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
state: A Coruña
city: Santiago
country: Spain
facility: Research Site
state: A Coruña
city: Viladecans
country: Spain
facility: Research Site
state: Barcelona
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Arbrå
country: Sweden
facility: Research Site
city: Gullspång
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Höganäs
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Kristinehamn
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Rättvik
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsbruk
country: Sweden
facility: Research Site
city: Södertälje
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Täby
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Upplands Väsby
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
facility: Research Site
city: Värnamo
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Ängelholm
country: Sweden
facility: Research Site
city: Baden
country: Switzerland
facility: Research Site
state: AG
city: Frick
country: Switzerland
facility: Research Site
state: AG
city: Spreitenbach
country: Switzerland
facility: Research Site
state: Zurich
city: Basel
country: Switzerland
facility: Research Site
city: Ennetbaden
country: Switzerland
facility: Research Site
city: Sargans
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
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.
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.