Nexium Dyspepsia/AST
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.
2 other identifiers
interventional
1,200
13 countries
183
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
183 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.
- Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach).
You may not qualify if:
- 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 (183)
Research Site
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
Related Publications (2)
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.
PMID: 21848799DERIVEDvan 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.
PMID: 17697200DERIVED
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