Nexium Dyspepsia/AST
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.
2 other identifiers
interventional
1,500
17 countries
215
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2002
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedJanuary 24, 2011
January 1, 2011
2.1 years
November 9, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (215)
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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
Related Publications (2)
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.
PMID: 19577008DERIVEDTalley 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.
PMID: 17697201DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
December 1, 2002
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
January 24, 2011
Record last verified: 2011-01