Nexium Dyspepsia/AST

Dyspepsia Clinical Trial

Official title:

Supportive Test for Acid-Related Symptoms (STARS I) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251914
• Other study ID #: SD-NED-0021
• Secondary ID: D9610C00021
• 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: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• 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: 1500
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.

• Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach)

Exclusion Criteria:

• Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment.

• 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
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Mendoza
Argentina	Research Site	Rosario
Argentina	Research Site	Santa Fe
Argentina	Research Site	Tucumán
Belgium	Research Site	Aalst
Belgium	Research Site	Andenne
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brugge
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels (Etterbeek)
Belgium	Research Site	Brussels (Jette)
Belgium	Research Site	Brussels (Laeken)
Belgium	Research Site	Brussels (Woluwé-St-Lambert)
Belgium	Research Site	Chimay
Belgium	Research Site	Damme
Belgium	Research Site	Edegem
Belgium	Research Site	Eupen
Belgium	Research Site	Genk
Belgium	Research Site	Godinne
Belgium	Research Site	Haine-Saint-Paul
Belgium	Research Site	Kortenberg
Belgium	Research Site	Kortrijk
Belgium	Research Site	Liège
Belgium	Research Site	Roeselare
Belgium	Research Site	Sijsele
Belgium	Research Site	Soignies
Belgium	Research Site	Turnhout
Belgium	Research Site	Wetteren
Belgium	Research Site	Yvoir
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Blumenau
Brazil	Research Site	Botucatu
Brazil	Research Site	Campinas
Brazil	Research Site	Florianópolis
Brazil	Research Site	Pelotas
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	Salvador
Brazil	Research Site	São Paulo
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Charlottetown	Prince Edward Island
Canada	Research Site	Conception Bay South	Newfoundland and Labrador
Canada	Research Site	Coquitlam	British Columbia
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Langley	British Columbia
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	North York	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Richmond Hill	Ontario
Canada	Research Site	Saint-Leonard	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Windsor	Ontario
Canada	Research Site	Winnipeg	Manitoba
Denmark	Research Site	Aalborg
Denmark	Research Site	Århus
Denmark	Research Site	Birkerød
Denmark	Research Site	Glostrup
Denmark	Research Site	Hellerup
Denmark	Research Site	Herning
Denmark	Research Site	Holbæk
Denmark	Research Site	København K
Denmark	Research Site	Odense C
Denmark	Research Site	Viborg
France	Research Site	Ales
France	Research Site	Angers
France	Research Site	Belfort
France	Research Site	BOIS GUILLAUME Cedex
France	Research Site	Cannes La Bocca
France	Research Site	Charenton Le Pont
France	Research Site	Clermont Ferrand
France	Research Site	Creteil
France	Research Site	Dreux
France	Research Site	Epernay
France	Research Site	Evreux
France	Research Site	Issoire
France	Research Site	Langon
France	Research Site	Lille
France	Research Site	Montelimar
France	Research Site	MONTELIMAR Cedex
France	Research Site	Nantes
France	Research Site	Narbonne
France	Research Site	Paris
France	Research Site	Rennes
France	Research Site	Saint Denis
France	Research Site	Saint Priest
France	Research Site	Talence
France	Research Site	Vitry Sur Seine
Germany	Research Site	Berlin
Germany	Research Site	Biederitz
Germany	Research Site	Cottbus	Brandenburg
Germany	Research Site	Dresden	Sachsen
Germany	Research Site	Halle	Sachsen-Anhalt
Germany	Research Site	Leipzig
Germany	Research Site	Magdeburg
Germany	Research Site	Magdeburg	Sachsen-Anhalt
Germany	Research Site	Mandelbachtal-Ommersheim
Germany	Research Site	Potsdam
Germany	Research Site	Saarbrücken	Saarland
Greece	Research Site	Athens
Greece	Research Site	Piraeus
Greece	Research Site	Thessaloniki
Iceland	Research Site	Hafnarfjördur
Iceland	Research Site	Reykjavik
Italy	Research Site	Biella	BI
Italy	Research Site	Bologna
Italy	Research Site	Brescia	BS
Italy	Research Site	Castellammare Di Stabia
Italy	Research Site	Catania	CT
Italy	Research Site	Como	CO
Italy	Research Site	Cremona	CR
Italy	Research Site	L'Aquila	AQ
Italy	Research Site	Milano	MI
Italy	Research Site	Pisa	PI
Italy	Research Site	Reggio Calabria	RC
Italy	Research Site	Roma
Italy	Research Site	San Benedetto Del Tronto	AP
Italy	Research Site	San Cataldo	CL
Italy	Research Site	San Daniele Del Friuli	UD
Italy	Research Site	Sondalo	SO
Italy	Research Site	Sondrio	SO
Italy	Research Site	Torino	TO
Italy	Research Site	Torre Del Greco
Italy	Research Site	Udine	UD
Norway	Research Site	Aksdal
Norway	Research Site	Arendal
Norway	Research Site	Bergen
Norway	Research Site	Bøverbru
Norway	Research Site	Brumunddal
Norway	Research Site	Eidehavn
Norway	Research Site	Elverum
Norway	Research Site	Fevik
Norway	Research Site	Fitjar
Norway	Research Site	Flatåsen
Norway	Research Site	Fredrikstad
Norway	Research Site	Fyllingsdalen
Norway	Research Site	Hafrsfjord
Norway	Research Site	Hafslundsøy
Norway	Research Site	Hamar
Norway	Research Site	Heimdal
Norway	Research Site	Høvik
Norway	Research Site	Jessheim
Norway	Research Site	Kokstad
Norway	Research Site	Kolbjørnsvik
Norway	Research Site	Langesund
Norway	Research Site	Larvik
Norway	Research Site	Løten
Norway	Research Site	Løvenstad
Norway	Research Site	Moss
Norway	Research Site	Nesttun
Norway	Research Site	Oslo
Norway	Research Site	Paradis
Norway	Research Site	Rasta
Norway	Research Site	Rolvsøy
Norway	Research Site	Ski
Norway	Research Site	Sogndal
Norway	Research Site	Sørumsand
Norway	Research Site	Spydeberg
Norway	Research Site	Stjørdal
Norway	Research Site	Svelvik
Norway	Research Site	Trondheim
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Tg. Mures
Romania	Research Site	Tirgu Mures
Singapore	Research Site	Singapore
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Lyttelton Manor
South Africa	Research Site	Parktown
South Africa	Research Site	Pretoria
South Africa	Research Site	Tygerberg
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Santiago	A Coruña
Spain	Research Site	Santiago de Compostela	A Coruña
Spain	Research Site	Sevilla
Spain	Research Site	Viladecans	Barcelona
Sweden	Research Site	Ängelholm
Sweden	Research Site	Arbrå
Sweden	Research Site	Göteborg
Sweden	Research Site	Gullspång
Sweden	Research Site	Höganäs
Sweden	Research Site	Jönköping
Sweden	Research Site	Kristinehamn
Sweden	Research Site	Lund
Sweden	Research Site	Malmö
Sweden	Research Site	Rättvik
Sweden	Research Site	Skövde
Sweden	Research Site	Södertälje
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsbruk
Sweden	Research Site	Täby
Sweden	Research Site	Trollhättan
Sweden	Research Site	Uddevalla
Sweden	Research Site	Upplands Väsby
Sweden	Research Site	Varberg
Sweden	Research Site	Värnamo
Sweden	Research Site	Västerås
Switzerland	Research Site	Baden	AG
Switzerland	Research Site	Basel
Switzerland	Research Site	Ennetbaden
Switzerland	Research Site	Frick	AG
Switzerland	Research Site	Sargans
Switzerland	Research Site	Spreitenbach	Zurich
Switzerland	Research Site	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Canada,  Denmark,  France,  Germany,  Greece,  Iceland,  Italy,  Norway,  Romania,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland, 

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