Nexium Dyspepsia/AST

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251992
First received: November 9, 2005
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Disease
Signs and Symptoms, Digestive
Dyspepsia
Drug: Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 1200
Study Start Date: December 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251992

  Hide Study Locations
Locations
Austria
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Braunau, Austria
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Graz, Austria
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Krems, Austria
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Linz, Austria
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Salzburg, Austria
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Sankt Pölten, Austria
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St. Johann, Austria
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Wien, Austria
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Wiener Neustadt, Austria
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Zell am See, Austria
Belgium
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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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Linkebeek, Belgium
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Liège, 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
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, British Columbia
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Kelowna, British Columbia, Canada
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Penticton, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
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Elmsdale, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
Canada, Ontario
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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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Orleans, 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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Sainte Gedeon-de-Beauce, Ontario, Canada
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Scarborough, Ontario, Canada
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St Catherines, 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
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
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Parkdale, Prince Edward Island, Canada
Canada, Quebec
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Charlesbourg, Quebec, Canada
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Granby, Quebec, Canada
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Saint-Leonard, Quebec, Canada
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Sainte-Foy, Quebec, Canada
Finland
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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
France
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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 Cedex, France
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NANCY Cedex, France
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Saint-ouen, France
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Vieux Conde, France
Germany
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Lochham, Germany
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München, Germany
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Rödental, Germany
Hungary
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Budapest, Hungary
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Budaörs, 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
Mexico
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Mexico, 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
Norway
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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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Rykkinn, Norway
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Rådal, 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
South Africa
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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
Sweden
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Fritsla, Sweden
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Göteborg, 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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Norrtälje, Sweden
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Nässjö, 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 Väsby, Sweden
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Vällingby, Sweden
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Västerås, Sweden
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Växjö, Sweden
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Ängelholm, Sweden
Switzerland
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Schönbühl-Urtenen, Bern, Switzerland
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Egg bei Zürich, Zürich, Switzerland
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Winterthur, Zürich, 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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Zürich, Switzerland
United Kingdom
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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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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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Tunbridge Wells, United Kingdom
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Watford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00251992     History of Changes
Other Study ID Numbers: SD-NED-0022, D9610C00022
Study First Received: November 9, 2005
Last Updated: January 21, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dyspepsia
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014