Nexium Dyspepsia/AST

NCT ID: NCT00251992

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

1200 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.
* Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach).

Exclusion Criteria

* 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

50 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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Braunau am Inn, , Austria

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Graz, , Austria

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Krems, , Austria

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Linz, , Austria

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Saint Johann, , Austria

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Salzburg, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Wiener Neustadt, , Austria

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Zell am See, , Austria

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Ans, , Belgium

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Brussels (Uccle), , Belgium

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Gozée, , Belgium

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Halle, , Belgium

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Kontich, , Belgium

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Kortenberg, , Belgium

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Kraainem, , Belgium

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Liège, , Belgium

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Linkebeek, , Belgium

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Massemen, , Belgium

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Moerkerke, , Belgium

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Natoye, , Belgium

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Oud-Heverlee, , Belgium

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Saint-Médard, , Belgium

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Soignies, , Belgium

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Waremme, , Belgium

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Wezembeek-Oppem, , Belgium

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Wingene, , Belgium

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Zoersel, , Belgium

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Zolder, , Belgium

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Zonhoven, , Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Penticton, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Elmsdale, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Dorchester, Ontario, Canada

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Hamilton, Ontario, Canada

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Kanata, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Niagara Falls, Ontario, Canada

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North York, Ontario, Canada

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Orléans, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Sainte Gedeon-de-Beauce, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Stirling, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Tottenham, Ontario, Canada

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Whitby, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Parkdale, Prince Edward Island, Canada

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Charlesbourg, Quebec, Canada

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Granby, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Espoo, , Finland

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Helsinki, , Finland

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Kouvola, , Finland

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Lempäälä, , Finland

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Pirkkala, , Finland

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Pori, , Finland

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Sahalahti, , Finland

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Tampere, , Finland

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Vääksy, , Finland

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Angers, , France

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Dambach-la-Ville, , France

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Dijon, , France

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La Seyne-sur-Mer, , France

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Laxou, , France

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Louviers, , France

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Mont-de-Marsan, , France

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Nancy, , France

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Saint-Ouen, , France

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Vieux-Condé, , France

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Lochham, , Germany

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München, , Germany

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Rödental, , Germany

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Budaörs, , Hungary

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Budapest, , Hungary

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Esztergom, , Hungary

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Hatvan, , Hungary

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Nagykanizsa, , Hungary

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Siófok, , Hungary

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Tát, , Hungary

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Zalaegerszeg, , Hungary

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México, D.F, Mexico

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Culiacán, , Mexico

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Guadalajara, , Mexico

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León, , Mexico

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México, , Mexico

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Torreón, , Mexico

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Bekkestua, , Norway

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Bergen, , Norway

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Hønefoss, , Norway

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Lier, , Norway

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Lysaker, , Norway

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Moss, , Norway

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Oslo, , Norway

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Paradis, , Norway

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Rådal, , Norway

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Rykkin, , Norway

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Sandefjord, , Norway

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Skien, , Norway

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Søgne, , Norway

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Tvedestrand, , Norway

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Østerås, , Norway

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Lenasia, Gauteng, South Africa

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Bloemfontein, , South Africa

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Boksburg, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Halfway House, , South Africa

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Lyttelton Manor, , South Africa

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Pretoria, , South Africa

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Ängelholm, , Sweden

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Fritsla, , Sweden

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Gothenburg, , Sweden

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Halmstad, , Sweden

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Höganäs, , Sweden

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Ingelstad, , Sweden

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Jönköping, , Sweden

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Kalmar, , Sweden

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Kilafors, , Sweden

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Kristinehamn, , Sweden

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Kungsör, , Sweden

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Motala, , Sweden

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Munkedal, , Sweden

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Nässjö, , Sweden

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Norrtälje, , Sweden

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Rättvik, , Sweden

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Staffanstorp, , Sweden

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Sundsbruk, , Sweden

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Trollhättan, , Sweden

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Uddevalla, , Sweden

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Upplands Vasby, , Sweden

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Vaxjo, , Sweden

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Vällingby, , Sweden

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Västerås, , Sweden

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Schönbühl-Urtenen, Canton of Bern, Switzerland

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Egg Bei Zürich, Canton of Zurich, Switzerland

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Winterthur, Canton of Zurich, Switzerland

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Zurich, Canton of Zurich, Switzerland

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Aarau, , Switzerland

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Brittnau, , Switzerland

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Küttigen, , Switzerland

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Schaffhausen, , Switzerland

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Zurich, , Switzerland

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Ely, Cambridgeshire, United Kingdom

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Woking, Surrey, United Kingdom

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Audley, , United Kingdom

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Blackburn, , United Kingdom

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Blackpool, , United Kingdom

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Chesterfield, , United Kingdom

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Coventry, , United Kingdom

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Enfield, , United Kingdom

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Glasgow, , United Kingdom

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Hadleigh, , United Kingdom

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Harrow, , United Kingdom

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Irvine, , United Kingdom

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Mansfield, , United Kingdom

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Nottingham, , United Kingdom

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Royal Tunbridge Wells, , United Kingdom

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Sheffield, , United Kingdom

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Shrewsbury, , United Kingdom

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Slough, , United Kingdom

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Titchfield, , United Kingdom

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Tonbridge, , United Kingdom

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Watford, , United Kingdom

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Countries

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Austria Belgium Canada Finland France Germany Hungary Mexico Norway South Africa Sweden Switzerland United Kingdom

References

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van Zanten SV, Wahlqvist P, Talley NJ, Halling K, Vakil N, Lauritsen K, Flook N, Persson T, Bolling-Sternevald E; STARS II Investigators. Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study. Aliment Pharmacol Ther. 2011 Oct;34(7):714-23. doi: 10.1111/j.1365-2036.2011.04789.x. Epub 2011 Aug 17.

Reference Type DERIVED
PMID: 21848799 (View on PubMed)

van Zanten SV, Flook N, Talley NJ, Vakil N, Lauritsen K, Bolling-Sternevald E, Persson T, Bjorck E, Svedberg LE; STARS II Study Group. One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study. Aliment Pharmacol Ther. 2007 Sep 1;26(5):665-72. doi: 10.1111/j.1365-2036.2007.03409.x.

Reference Type DERIVED
PMID: 17697200 (View on PubMed)

Other Identifiers

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D9610C00022

Identifier Type: -

Identifier Source: secondary_id

SD-NED-0022

Identifier Type: -

Identifier Source: org_study_id

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