Clinical trial NCT00251992: Nexium Dyspepsia/AST
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Disease
Signs and Symptoms, Digestive
Dyspepsia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
measure: The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
measure: 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:
measure: The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
measure: The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
measure: Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy
Other outcomes:
Locations:
city: Braunau
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Krems
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Sankt Pölten
country: Austria
facility: Research Site
city: St. Johann
country: Austria
facility: Research Site
city: Wiener Neustadt
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Zell am See
country: Austria
facility: Research Site
city: Ans
country: Belgium
facility: Research Site
city: Brussels (Uccle)
country: Belgium
facility: Research Site
city: Gozée
country: Belgium
facility: Research Site
city: Halle
country: Belgium
facility: Research Site
city: Kontich
country: Belgium
facility: Research Site
city: Kortenberg
country: Belgium
facility: Research Site
city: Kraainem
country: Belgium
facility: Research Site
city: Linkebeek
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Massemen
country: Belgium
facility: Research Site
city: Moerkerke
country: Belgium
facility: Research Site
city: Natoye
country: Belgium
facility: Research Site
city: Oud-Heverlee
country: Belgium
facility: Research Site
city: Saint-Médard
country: Belgium
facility: Research Site
city: Soignies
country: Belgium
facility: Research Site
city: Waremme
country: Belgium
facility: Research Site
city: Wezembeek- Oppem
country: Belgium
facility: Research Site
city: Wingene
country: Belgium
facility: Research Site
city: Zoersel
country: Belgium
facility: Research Site
city: Zolder
country: Belgium
facility: Research Site
city: Zonhoven
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Kelowna
country: Canada
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state: British Columbia
city: Penticton
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Bay Roberts
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Elmsdale
country: Canada
facility: Research Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Brampton
country: Canada
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state: Ontario
city: Burlington
country: Canada
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state: Ontario
city: Dorchester
country: Canada
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state: Ontario
city: Hamilton
country: Canada
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state: Ontario
city: Kanata
country: Canada
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state: Ontario
city: Kitchener
country: Canada
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state: Ontario
city: London
country: Canada
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state: Ontario
city: Markham
country: Canada
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state: Ontario
city: Mississauga
country: Canada
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state: Ontario
city: Niagara Falls
country: Canada
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state: Ontario
city: North York
country: Canada
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city: Orleans
country: Canada
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state: Ontario
city: Oshawa
country: Canada
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state: Ontario
city: Ottawa
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city: Richmond Hill
country: Canada
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state: Ontario
city: Sainte Gedeon-de-Beauce
country: Canada
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state: Ontario
city: Scarborough
country: Canada
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state: Ontario
city: St Catherines
country: Canada
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state: Ontario
city: Stirling
country: Canada
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state: Ontario
city: Thunder Bay
country: Canada
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state: Ontario
city: Toronto
country: Canada
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city: Tottenham
country: Canada
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city: Whitby
country: Canada
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state: Ontario
city: Charlottetown
country: Canada
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state: Prince Edward Island
city: Parkdale
country: Canada
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state: Prince Edward Island
city: Charlesbourg
country: Canada
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state: Quebec
city: Granby
country: Canada
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state: Quebec
city: Saint-Leonard
country: Canada
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state: Quebec
city: Sainte-Foy
country: Canada
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state: Quebec
city: Espoo
country: Finland
facility: Research Site
city: Helsinki
country: Finland
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city: Kouvola
country: Finland
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city: Lempäälä
country: Finland
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city: Pirkkala
country: Finland
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city: Pori
country: Finland
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city: Sahalahti
country: Finland
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city: Tampere
country: Finland
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city: Vääksy
country: Finland
facility: Research Site
city: Angers
country: France
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city: Dambach La Ville
country: France
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city: Dijon
country: France
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city: La Seyne Sur Mer
country: France
facility: Research Site
city: Laxou
country: France
facility: Research Site
city: Louviers
country: France
facility: Research Site
city: MONT DE MARSAN Cedex
country: France
facility: Research Site
city: NANCY Cedex
country: France
facility: Research Site
city: Saint-ouen
country: France
facility: Research Site
city: Vieux Conde
country: France
facility: Research Site
city: Lochham
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Rödental
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budaörs
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Hatvan
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Siófok
country: Hungary
facility: Research Site
city: Tát
country: Hungary
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city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Mexico
country: Mexico
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state: D.F
city: Culiacán
country: Mexico
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city: Guadalajara
country: Mexico
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city: León
country: Mexico
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city: México
country: Mexico
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city: Torreón
country: Mexico
facility: Research Site
city: Bekkestua
country: Norway
facility: Research Site
city: Bergen
country: Norway
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city: Hønefoss
country: Norway
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city: Lier
country: Norway
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city: Lysaker
country: Norway
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city: Moss
country: Norway
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city: Oslo
country: Norway
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city: Paradis
country: Norway
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city: Rykkinn
country: Norway
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city: Rådal
country: Norway
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city: Sandefjord
country: Norway
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city: Skien
country: Norway
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city: Søgne
country: Norway
facility: Research Site
city: Tvedestrand
country: Norway
facility: Research Site
city: Østerås
country: Norway
facility: Research Site
city: Lenasia
country: South Africa
facility: Research Site
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Research Site
city: Boksburg
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
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city: Halfway House
country: South Africa
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city: Lyttelton Manor
country: South Africa
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city: Pretoria
country: South Africa
facility: Research Site
city: Fritsla
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Halmstad
country: Sweden
facility: Research Site
city: Höganäs
country: Sweden
facility: Research Site
city: Ingelstad
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Kalmar
country: Sweden
facility: Research Site
city: Kilafors
country: Sweden
facility: Research Site
city: Kristinehamn
country: Sweden
facility: Research Site
city: Kungsör
country: Sweden
facility: Research Site
city: Motala
country: Sweden
facility: Research Site
city: Munkedal
country: Sweden
facility: Research Site
city: Norrtälje
country: Sweden
facility: Research Site
city: Nässjö
country: Sweden
facility: Research Site
city: Rättvik
country: Sweden
facility: Research Site
city: Staffanstorp
country: Sweden
facility: Research Site
city: Sundsbruk
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Upplands Väsby
country: Sweden
facility: Research Site
city: Vällingby
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Växjö
country: Sweden
facility: Research Site
city: Ängelholm
country: Sweden
facility: Research Site
city: Schönbühl-Urtenen
country: Switzerland
facility: Research Site
state: Bern
city: Egg bei Zürich
country: Switzerland
facility: Research Site
state: Zürich
city: Winterthur
country: Switzerland
facility: Research Site
state: Zürich
city: Aarau
country: Switzerland
facility: Research Site
city: Brittnau
country: Switzerland
facility: Research Site
city: Küttigen
country: Switzerland
facility: Research Site
city: Schaffhausen
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Ely
country: United Kingdom
facility: Research Site
state: Cambridgeshire
city: Woking
country: United Kingdom
facility: Research Site
state: Surrey
city: Audley
country: United Kingdom
facility: Research Site
city: Blackburn
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Enfield
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hadleigh
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Irvine
country: United Kingdom
facility: Research Site
city: Mansfield
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
city: Slough
country: United Kingdom
facility: Research Site
city: Titchfield
country: United Kingdom
facility: Research Site
city: Tonbridge
country: United Kingdom
facility: Research Site
city: Tunbridge Wells
country: United Kingdom
facility: Research Site
city: Watford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.