Gastrointestinal DiseasePhase 3NCT00251914
Nexium Dyspepsia/AST
A Phase 3 study testing Esomeprazole in people with Gastrointestinal Disease and Signs and Symptoms, Digestive, run by AstraZeneca at 215 sites in 17 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia
- What is being tested?
- Esomeprazole
- How many people
- 1,500 participants
- Where
- 215 sitesin 17 countries
- Study dates
- Dec 2002to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
215 sites in 17 countries.
215 sites in 17 countries
Norway37 sites
Research Site
Aksdal
Research Site
Arendal
Research Site
Bergen
Research Site
Bøverbru
Research Site
Brumunddal
Research Site
Eidehavn
Research Site
Elverum
Research Site
Fevik
Research Site
Fitjar
Research Site
Flatåsen
Research Site
Fredrikstad
Research Site
Fyllingsdalen
Research Site
Hafrsfjord
Research Site
Hafslundsøy
Research Site
Hamar
Research Site
Heimdal
Research Site
Høvik
Research Site
Jessheim
Research Site
Kokstad
Research Site
Kolbjørnsvik
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Langesund
Research Site
Larvik
Research Site
Løten
Research Site
Løvenstad
Research Site
Moss
Research Site
Nesttun
Research Site
Oslo
Research Site
Paradis
Research Site
Rasta
Research Site
Rolvsøy
Research Site
Ski
Research Site
Sogndal
Research Site
Sørumsand
Research Site
Spydeberg
Research Site
Stjørdal
Research Site
Svelvik
Research Site
Trondheim
Belgium25 sites
Research Site
Aalst
Research Site
Andenne
Research Site
Bonheiden
Research Site
Bruges
Research Site
Brussels
Research Site
Brussels (Etterbeek)
Research Site
Brussels (Jette)
Research Site
Brussels (Laeken)
Research Site
Brussels (Woluwé-St-Lambert)
Research Site
Chimay
Research Site
Damme
Research Site
Edegem
Research Site
Eupen
Research Site
Genk
Research Site
Godinne
Research Site
Haine-Saint-Paul
Research Site
Kortenberg
Research Site
Kortrijk
Research Site
Liège
Research Site
Roeselare
Research Site
Sijsele
Research Site
Soignies
Research Site
Turnhout
Research Site
Wetteren
Research Site
Yvoir
Canada23 sites
Research Site
Brampton, Ontario
Research Site
Charlottetown, Prince Edward Island
Research Site
Conception Bay South, Newfoundland and Labrador
Research Site
Coquitlam, British Columbia
Research Site
Courtice, Ontario
Research Site
Edmonton, Alberta
Research Site
Etobicoke, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Hamilton, Ontario
Research Site
Langley, British Columbia
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
North York, Ontario
Research Site
Oshawa, Ontario
Research Site
Pointe-Claire, Quebec
Research Site
Richmond Hill, Ontario
Research Site
Saint-Léonard, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Research Site
Windsor, Ontario
Research Site
Winnipeg, Manitoba
France23 sites
Research Site
Alès
Research Site
Angers
Research Site
Belfort
Research Site
Bois-Guillaume
Research Site
Cannes La Bocca
Research Site
Charenton-le-Pont
Research Site
Clermont-Ferrand
Research Site
Créteil
Research Site
Dreux
Research Site
Épernay
Research Site
Évreux
Research Site
Issoire
Research Site
Langon
Research Site
Lille
Research Site
Montélimar
Research Site
Nantes
Research Site
Narbonne
Research Site
Paris
Research Site
Rennes
Research Site
Saint-Denis
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Saint-Priest
Research Site
Talence
Research Site
Vitry-sur-Seine
Sweden21 sites
Research Site
Ängelholm
Research Site
Arbrå
Research Site
Gothenburg
Research Site
Gullspång
Research Site
Höganäs
Research Site
Jönköping
Research Site
Kristinehamn
Research Site
Lund
Research Site
Malmö
Research Site
Rättvik
Research Site
Skövde
Research Site
Södertälje
Research Site
Stockholm
Research Site
Sundsbruk
Research Site
Täby
Research Site
Trollhättan
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Uddevalla
Research Site
Upplands Vasby
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Varberg
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Värnamo
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Västerås
Italy20 sites
Research Site
Biella, BI
Research Site
Bologna
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Brescia, BS
Research Site
Castellammare di Stabia
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Catania, CT
Research Site
Como, CO
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Cremona, CR
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L’Aquila, AQ
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Milan, MI
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Pisa, PI
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Reggio Calabria, RC
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Roma, Roma
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San Benedetto del Tronto, AP
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San Cataldo, CL
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San Daniele del Friuli, UD
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Sondalo, SO
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Sondrio, SO
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Torino, TO
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Torre del Greco
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Udine, UD
Germany11 sites
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Berlin
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Biederitz
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Cottbus, Brandenburg
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Dresden, Saxony
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Halle, Saxony-Anhalt
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Leipzig
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Magdeburg, Saxony-Anhalt
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Magdeburg
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Mandelbachtal-Ommersheim
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Potsdam
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Saarbrücken, Saarland
Denmark10 sites
Research Site
Aalborg
Research Site
Aarhus
Research Site
Birkerød
Research Site
Glostrup Municipality
Research Site
Hellerup
Research Site
Herning
Research Site
Holbæk
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København K
Research Site
Odense C
Research Site
Viborg
Brazil9 sites
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Belo Horizonte
Research Site
Blumenau
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Botucatu
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Campinas
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Florianópolis
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Pelotas
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Rio de Janeiro, Rio de Janeiro
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Salvador
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São Paulo
South Africa8 sites
Research Site
Bloemfontein
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Cape Town
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Durban
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Johannesburg
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Lyttelton Manor
Research Site
Parktown
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Pretoria
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Tygerberg
Switzerland7 sites
Research Site
Baden, Canton of Aargau
Research Site
Basel
Research Site
Ennetbaden
Research Site
Frick, Canton of Aargau
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Sankt Gallen
Research Site
Sargans
Research Site
Spreitenbach, Canton of Zurich
Spain6 sites
Research Site
Barcelona, Barcelona
Research Site
Madrid, Madrid
Research Site
Santiago, A Coruña
Research Site
Santiago de Compostela, A Coruña
Research Site
Seville, Sevilla
Research Site
Viladecans, Barcelona
Argentina5 sites
Research Site
Buenos Aires
Research Site
Mendoza
Research Site
Rosario
Research Site
San Miguel de Tucumán
Research Site
Santa Fe
Romania4 sites
Research Site
Brasov
Research Site
Bucharest
Research Site
Târgu Mureş
Research Site
Tg. Mures
Greece3 sites
Research Site
Athens
Research Site
Piraeus
Research Site
Thessaloniki
About this study
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.
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.
- Being tested
- Esomeprazole
- Medical subject headings
- Gastrointestinal Diseases, Signs and Symptoms, Digestive, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startDec 2002
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251914
- Sponsor's protocol ID
- SD-NED-0021
- Other IDs
- D9610C00021
- Status last verified
- Jan 2011
- First submitted
- 9 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Paggi S, Radaelli F, Amato A, Meucci G, Mandelli G, Imperiali G, Spinzi G, Terreni N, Lenoci N, Terruzzi V. The impact of narrow band imaging in screening colonoscopy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1049-54. doi: 10.1016/j.cgh.2009.06.028. Epub 2009 Jul 1.
PubMed 19577008Talley NJ, Vakil N, Lauritsen K, van Zanten SV, Flook N, Bolling-Sternevald E, Persson T, Bjorck E, Lind T; STARS I Study Group. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning: does a 1-week trial of acid suppression predict symptom response? Aliment Pharmacol Ther. 2007 Sep 1;26(5):673-82. doi: 10.1111/j.1365-2036.2007.03410.x.
PubMed 17697201
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00251914
- Acronym / sponsor ID
- SD-NED-0021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
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).
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
- Derived from this study: PubMed 19577008Paggi S, Radaelli F, Amato A, Meucci G, Mandelli G, Imperiali G, Spinzi G, Terreni N, Lenoci N, Terruzzi V. The impact of narrow band imaging in screening colonoscopy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1049-54. doi: 10.1016/j.cgh.2009.06.028. Epub 2009 Jul 1.
- Derived from this study: PubMed 17697201Talley NJ, Vakil N, Lauritsen K, van Zanten SV, Flook N, Bolling-Sternevald E, Persson T, Bjorck E, Lind T; STARS I Study Group. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning: does a 1-week trial of acid suppression predict symptom response? Aliment Pharmacol Ther. 2007 Sep 1;26(5):673-82. doi: 10.1111/j.1365-2036.2007.03410.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Nexium Medical Sciences Director, MD study director
AstraZeneca
215 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Gastrointestinal Disease and Signs and Symptoms, Digestive, run by AstraZeneca at 215 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 215 sites in Norway, Belgium, Canada, France, Sweden and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is whether the patient is a responder or not after 8 weeks treatment.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.