Nexium Dyspepsia/AST

Condition(s) targeted: Gastrointestinal Disease; Signs and Symptoms, Digestive; Dyspepsia

Intervention: Esomeprazole (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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.

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.

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

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:

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Research Site, Calgary, Alberta, Canada

Research Site, Edmonton, Alberta, Canada

Research Site, Schönbühl-Urtenen, Bern, Switzerland

Research Site, Kelowna, British Columbia, Canada

Research Site, Penticton, British Columbia, Canada

Research Site, Ely, Cambridgeshire, United Kingdom

Research Site, Mexico, D.F, Mexico

Research Site, Lenasia, Gauteng, South Africa

Research Site, Motala, Sweden

Research Site, Munkedal, Sweden

Research Site, NÄSSJÖ, Sweden

Research Site, Norrtälje, Sweden

Research Site, Rättvik, Sweden

Research Site, Siófok, Hungary

Research Site, Tát, Hungary

Research Site, Zalaegerszeg, Hungary

Research Site, Culiacán, Mexico

Research Site, Guadalajara, Mexico

Research Site, Vääksy, Finland

Research Site, Angers, France

Research Site, Dambach-la-Ville, France

Research Site, Dijon, France

Research Site, La Seyne-sur-Mer, France

Research Site, Natoye, Belgium

Research Site, Zell am See, Austria

Research Site, León, Mexico

Research Site, Chesterfield, United Kingdom

Research Site, Coventry, United Kingdom

Research Site, Enfield, United Kingdom

Research Site, Glasgow, United Kingdom

Research Site, Audley, United Kingdom

Research Site, Blackburn, United Kingdom

Research Site, Blackpool, United Kingdom

Research Site, Kalmar, Sweden

Research Site, Kilafors, Sweden

Research Site, Kristinehamn, Sweden

Research Site, KUNGSÖR, Sweden

Research Site, Sandefjord, Norway

Research Site, Skien, Norway

Research Site, SØGNE, Norway

Research Site, Tvedestrand, Norway

Research Site, Bloemfontein, South Africa

Research Site, Saint-Ouen, France

Research Site, Vieux Conde, France

Research Site, Lochham, Germany

Research Site, München, Germany

Research Site, Rödental, Germany

Research Site, Hadleigh, United Kingdom

Research Site, Harrow, United Kingdom

Research Site, Irvine, United Kingdom

Research Site, Mansfield, United Kingdom

Research Site, Nottingham, United Kingdom

Research Site, Durban, South Africa

Research Site, Pretoria, South Africa

Research Site, Ängelholm, Sweden

Research Site, Fritsla, Sweden

Research Site, Sheffield, United Kingdom

Research Site, Shrewsbury, United Kingdom

Research Site, Slough, United Kingdom

Research Site, Titchfield, United Kingdom

Research Site, Tonbridge, United Kingdom

Research Site, Vällingby, Sweden

Research Site, Västerås, Sweden

Research Site, Växjö, Sweden

Research Site, Aarau, Switzerland

Research Site, Linkebeek, Belgium

Research Site, St. Johann, Austria

Research Site, Wezembeek- Oppem, Belgium

Research Site, Gozée, Belgium

Research Site, Moerkerke, Belgium

Research Site, Wiener Neustadt, Austria

Research Site, Brussels (Uccle), Belgium

Research Site, Braunau, Austria

Research Site, Zoersel, Belgium

Research Site, Ans, Belgium

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Research Site, Tunbridge Wells, United Kingdom

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Research Site, Kontich, Belgium

Research Site, Laxou, France

Research Site, Louviers, France

Research Site, MONT DE MARSAN Cedex, France

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Research Site, Bergen, Norway

Research Site, Hønefoss, Norway

Research Site, Lier, Norway

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Research Site, Moss, Norway

Research Site, Lempäälä, Finland

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Research Site, Pori, Finland

Research Site, Sahalahti, Finland

Research Site, Tampere, Finland

Research Site, Zonhoven, Belgium

Research Site, Brittnau, Switzerland

Research Site, Küttigen, Switzerland

Research Site, Schaffhausen, Switzerland

Research Site, ZÜRICH, Switzerland

Research Site, Massemen, Belgium

Research Site, Oud-Heverlee, Belgium

Research Site, Wingene, Belgium

Research Site, Zolder, Belgium

Research Site, Wien, Austria

Research Site, Soignies, Belgium

Research Site, Espoo, Finland

Research Site, Helsinki, Finland

Research Site, Kouvola, Finland

Research Site, Kraainem, Belgium

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Research Site, Liège, Belgium

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Research Site, México, Mexico

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Research Site, Budapest, Hungary

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Research Site, Esztergom, Hungary

Research Site, Hatvan, Hungary

Research Site, Nagykanizsa, Hungary

Research Site, Cape Town, South Africa

Research Site, Halfway House, South Africa

Research Site, Lyttelton Manor, South Africa

Research Site, Boksburg, South Africa

Research Site, Göteborg, Sweden

Research Site, Halmstad, Sweden

Research Site, Höganäs, Sweden

Research Site, INGELSTAD, Sweden

Research Site, Jönköping, Sweden

Research Site, Oslo, Norway

Research Site, Østerås, Norway

Research Site, Paradis, Norway

Research Site, Rådal, Norway

Research Site, Rykkinn, Norway

Research Site, STAFFANSTORP, Sweden

Research Site, SUNDSBRUK, Sweden

Research Site, Trollhättan, Sweden

Research Site, Uddevalla, Sweden

Research Site, Upplands Väsby, Sweden

Research Site, Winnipeg, Manitoba, Canada

Research Site, Bay Roberts, Newfoundland and Labrador, Canada

Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Elmsdale, Nova Scotia, Canada

Research Site, Halifax, Nova Scotia, Canada

Research Site, Ajax, Ontario, Canada

Research Site, Brampton, Ontario, Canada

Research Site, Burlington, Ontario, Canada

Research Site, Dorchester, Ontario, Canada

Research Site, Hamilton, Ontario, Canada

Research Site, Kanata, Ontario, Canada

Research Site, Kitchener, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, Markham, Ontario, Canada

Research Site, Mississauga, Ontario, Canada

Research Site, Niagara Falls, Ontario, Canada

Research Site, North York, Ontario, Canada

Research Site, Orleans, Ontario, Canada

Research Site, Oshawa, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, Richmond Hill, Ontario, Canada

Research Site, Sainte Gedeon-de-Beauce, Ontario, Canada

Research Site, Scarborough, Ontario, Canada

Research Site, St. Catherines, Ontario, Canada

Research Site, Stirling, Ontario, Canada

Research Site, Thunder Bay, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Tottenham, Ontario, Canada

Research Site, Whitby, Ontario, Canada

Research Site, Charlottetown, Prince Edward Island, Canada

Research Site, Parkdale, Prince Edward Island, Canada

Research Site, Charlesbourg, Quebec, Canada

Research Site, Granby, Quebec, Canada

Research Site, Sainte-Foy, Quebec, Canada

Research Site, Saint Leonard, Quebec, Canada

Research Site, Woking, Surrey, United Kingdom

Research Site, Egg bei Zürich, Zürich, Switzerland

Research Site, Winterthur, Zürich, Switzerland

Starting date: December 2002
Last updated: November 9, 2005