Nexium Dyspepsia/AST

NCT ID: NCT00251914

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-01-31

Brief Summary

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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

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Conditions

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Gastrointestinal Disease Signs and Symptoms, Digestive Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Esomeprazole

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Nexium Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Buenos Aires, , Argentina

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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

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Brussels (Etterbeek), , Belgium

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Brussels (Jette), , Belgium

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Brussels (Laeken), , Belgium

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Brussels (Woluwé-St-Lambert), , Belgium

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Chimay, , Belgium

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Damme, , Belgium

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Edegem, , Belgium

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Eupen, , Belgium

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Genk, , Belgium

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Godinne, , Belgium

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Haine-Saint-Paul, , Belgium

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Kortenberg, , Belgium

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Kortrijk, , Belgium

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Liège, , Belgium

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Roeselare, , Belgium

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Sijsele, , Belgium

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Soignies, , Belgium

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Turnhout, , Belgium

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Wetteren, , Belgium

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Yvoir, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Belo Horizonte, , Brazil

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Blumenau, , Brazil

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Botucatu, , Brazil

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Campinas, , Brazil

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Florianópolis, , Brazil

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Pelotas, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Conception Bay South, Newfoundland and Labrador, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Courtice, Ontario, Canada

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Mississauga, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Aalborg, , Denmark

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Aarhus, , Denmark

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Birkerød, , Denmark

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Glostrup Municipality, , Denmark

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Hellerup, , Denmark

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Herning, , Denmark

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Holbæk, , Denmark

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København K, , Denmark

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Odense C, , Denmark

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Viborg, , Denmark

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Alès, , France

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Angers, , France

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Belfort, , France

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Bois-Guillaume, , France

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Cannes La Bocca, , France

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Charenton-le-Pont, , France

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Clermont-Ferrand, , France

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Créteil, , France

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Dreux, , France

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Épernay, , France

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Évreux, , France

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Issoire, , France

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Langon, , France

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Lille, , France

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Montélimar, , France

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Nantes, , France

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Narbonne, , France

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Paris, , France

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Rennes, , France

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Saint-Denis, , France

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Saint-Priest, , France

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Talence, , France

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Vitry-sur-Seine, , France

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Cottbus, Brandenburg, Germany

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Saarbrücken, Saarland, Germany

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Dresden, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Berlin, , Germany

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Biederitz, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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Mandelbachtal-Ommersheim, , Germany

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Potsdam, , Germany

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Athens, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Hafnarfjördur, , Iceland

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Reykjavik, , Iceland

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San Benedetto del Tronto, AP, Italy

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L’Aquila, AQ, Italy

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Biella, BI, Italy

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Brescia, BS, Italy

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San Cataldo, CL, Italy

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Como, CO, Italy

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Cremona, CR, Italy

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Catania, CT, Italy

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Milan, MI, Italy

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Pisa, PI, Italy

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Reggio Calabria, RC, Italy

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Roma, Roma, Italy

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Sondalo, SO, Italy

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Sondrio, SO, Italy

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Torino, TO, Italy

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San Daniele del Friuli, UD, Italy

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Udine, UD, Italy

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Bologna, , Italy

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Castellammare di Stabia, , Italy

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Torre del Greco, , Italy

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Aksdal, , Norway

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Arendal, , Norway

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Bergen, , Norway

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Brumunddal, , Norway

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Bøverbru, , Norway

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Eidehavn, , Norway

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Elverum, , Norway

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Fevik, , Norway

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Fitjar, , Norway

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Flatåsen, , Norway

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Fredrikstad, , Norway

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Fyllingsdalen, , Norway

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Hafrsfjord, , Norway

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Hafslundsøy, , Norway

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Hamar, , Norway

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Heimdal, , Norway

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Høvik, , Norway

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Jessheim, , Norway

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Kokstad, , Norway

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Kolbjørnsvik, , Norway

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Langesund, , Norway

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Larvik, , Norway

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Løten, , Norway

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Løvenstad, , Norway

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Moss, , Norway

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Nesttun, , Norway

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Oslo, , Norway

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Paradis, , Norway

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Rasta, , Norway

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Rolvsøy, , Norway

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Ski, , Norway

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Sogndal, , Norway

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Spydeberg, , Norway

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Stjørdal, , Norway

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Svelvik, , Norway

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Sørumsand, , Norway

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Trondheim, , Norway

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Brasov, , Romania

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Bucharest, , Romania

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Târgu Mureş, , Romania

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Tg. Mures, , Romania

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Singapore, , Singapore

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Lyttelton Manor, , South Africa

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Parktown, , South Africa

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Pretoria, , South Africa

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Tygerberg, , South Africa

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Santiago, A Coruña, Spain

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Santiago de Compostela, A Coruña, Spain

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Barcelona, Barcelona, Spain

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Viladecans, Barcelona, Spain

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Madrid, Madrid, Spain

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Seville, Sevilla, Spain

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Arbrå, , Sweden

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Ängelholm, , Sweden

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Gothenburg, , Sweden

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Gullspång, , Sweden

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Höganäs, , Sweden

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Jönköping, , Sweden

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Kristinehamn, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Rättvik, , Sweden

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Skövde, , Sweden

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Södertälje, , Sweden

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Stockholm, , Sweden

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Sundsbruk, , Sweden

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Täby, , Sweden

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Trollhättan, , Sweden

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Uddevalla, , Sweden

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Upplands Vasby, , Sweden

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Varberg, , Sweden

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Värnamo, , Sweden

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Västerås, , Sweden

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Baden, Canton of Aargau, Switzerland

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Frick, Canton of Aargau, Switzerland

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Spreitenbach, Canton of Zurich, Switzerland

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Basel, , Switzerland

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Ennetbaden, , Switzerland

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Sankt Gallen, , Switzerland

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Sargans, , Switzerland

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Countries

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Argentina Belgium Brazil Canada Denmark France Germany Greece Iceland Italy Norway Romania Singapore South Africa Spain Sweden Switzerland

References

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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.

Reference Type DERIVED
PMID: 19577008 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17697201 (View on PubMed)

Other Identifiers

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D9610C00021

Identifier Type: -

Identifier Source: secondary_id

SD-NED-0021

Identifier Type: -

Identifier Source: org_study_id

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