Nexium Dyspepsia/AST

Dyspepsia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251992
• Other study ID #: SD-NED-0022
• Secondary ID: D9610C00022
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: January 21, 2011
• Start date: December 2002
• Est. completion date: January 2005

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Signs and Symptoms
• Signs and Symptoms, Digestive

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Austria	Research Site	Braunau
Austria	Research Site	Graz
Austria	Research Site	Krems
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	Sankt Pölten
Austria	Research Site	St. Johann
Austria	Research Site	Wien
Austria	Research Site	Wiener Neustadt
Austria	Research Site	Zell am See
Belgium	Research Site	Ans
Belgium	Research Site	Brussels (Uccle)
Belgium	Research Site	Gozée
Belgium	Research Site	Halle
Belgium	Research Site	Kontich
Belgium	Research Site	Kortenberg
Belgium	Research Site	Kraainem
Belgium	Research Site	Liège
Belgium	Research Site	Linkebeek
Belgium	Research Site	Massemen
Belgium	Research Site	Moerkerke
Belgium	Research Site	Natoye
Belgium	Research Site	Oud-Heverlee
Belgium	Research Site	Saint-Médard
Belgium	Research Site	Soignies
Belgium	Research Site	Waremme
Belgium	Research Site	Wezembeek- Oppem
Belgium	Research Site	Wingene
Belgium	Research Site	Zoersel
Belgium	Research Site	Zolder
Belgium	Research Site	Zonhoven
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Charlesbourg	Quebec
Canada	Research Site	Charlottetown	Prince Edward Island
Canada	Research Site	Dorchester	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Elmsdale	Nova Scotia
Canada	Research Site	Granby	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kanata	Ontario
Canada	Research Site	Kelowna	British Columbia
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	Parkdale	Prince Edward Island
Canada	Research Site	Penticton	British Columbia
Canada	Research Site	Richmond Hill	Ontario
Canada	Research Site	Saint-Leonard	Quebec
Canada	Research Site	Sainte Gedeon-de-Beauce	Ontario
Canada	Research Site	Sainte-Foy	Quebec
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	St Catherines	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
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	Winnipeg	Manitoba
Finland	Research Site	Espoo
Finland	Research Site	Helsinki
Finland	Research Site	Kouvola
Finland	Research Site	Lempäälä
Finland	Research Site	Pirkkala
Finland	Research Site	Pori
Finland	Research Site	Sahalahti
Finland	Research Site	Tampere
Finland	Research Site	Vääksy
France	Research Site	Angers
France	Research Site	Dambach La Ville
France	Research Site	Dijon
France	Research Site	La Seyne Sur Mer
France	Research Site	Laxou
France	Research Site	Louviers
France	Research Site	MONT DE MARSAN Cedex
France	Research Site	NANCY Cedex
France	Research Site	Saint-ouen
France	Research Site	Vieux Conde
Germany	Research Site	Lochham
Germany	Research Site	München
Germany	Research Site	Rödental
Hungary	Research Site	Budaörs
Hungary	Research Site	Budapest
Hungary	Research Site	Esztergom
Hungary	Research Site	Hatvan
Hungary	Research Site	Nagykanizsa
Hungary	Research Site	Siófok
Hungary	Research Site	Tát
Hungary	Research Site	Zalaegerszeg
Mexico	Research Site	Culiacán
Mexico	Research Site	Guadalajara
Mexico	Research Site	León
Mexico	Research Site	Mexico	D.F
Mexico	Research Site	México
Mexico	Research Site	Torreón
Norway	Research Site	Bekkestua
Norway	Research Site	Bergen
Norway	Research Site	Hønefoss
Norway	Research Site	Lier
Norway	Research Site	Lysaker
Norway	Research Site	Moss
Norway	Research Site	Oslo
Norway	Research Site	Østerås
Norway	Research Site	Paradis
Norway	Research Site	Rådal
Norway	Research Site	Rykkinn
Norway	Research Site	Sandefjord
Norway	Research Site	Skien
Norway	Research Site	Søgne
Norway	Research Site	Tvedestrand
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Boksburg
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Halfway House
South Africa	Research Site	Lenasia	Gauteng
South Africa	Research Site	Lyttelton Manor
South Africa	Research Site	Pretoria
Sweden	Research Site	Ängelholm
Sweden	Research Site	Fritsla
Sweden	Research Site	Göteborg
Sweden	Research Site	Halmstad
Sweden	Research Site	Höganäs
Sweden	Research Site	Ingelstad
Sweden	Research Site	Jönköping
Sweden	Research Site	Kalmar
Sweden	Research Site	Kilafors
Sweden	Research Site	Kristinehamn
Sweden	Research Site	Kungsör
Sweden	Research Site	Motala
Sweden	Research Site	Munkedal
Sweden	Research Site	Nässjö
Sweden	Research Site	Norrtälje
Sweden	Research Site	Rättvik
Sweden	Research Site	Staffanstorp
Sweden	Research Site	Sundsbruk
Sweden	Research Site	Trollhättan
Sweden	Research Site	Uddevalla
Sweden	Research Site	Upplands Väsby
Sweden	Research Site	Vällingby
Sweden	Research Site	Västerås
Sweden	Research Site	Växjö
Switzerland	Research Site	Aarau
Switzerland	Research Site	Brittnau
Switzerland	Research Site	Egg bei Zürich	Zürich
Switzerland	Research Site	Küttigen
Switzerland	Research Site	Schaffhausen
Switzerland	Research Site	Schönbühl-Urtenen	Bern
Switzerland	Research Site	Winterthur	Zürich
Switzerland	Research Site	Zürich
United Kingdom	Research Site	Audley
United Kingdom	Research Site	Blackburn
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Ely	Cambridgeshire
United Kingdom	Research Site	Enfield
United Kingdom	Research Site	Glasgow
United Kingdom	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	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	Tunbridge Wells
United Kingdom	Research Site	Watford
United Kingdom	Research Site	Woking	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
Primary	The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
Primary	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	The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
Secondary	The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
Secondary	Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy