Gastrointestinal DiseasePhase 3NCT00251992

Nexium Dyspepsia/AST

A Phase 3 study testing Esomeprazole in people with Gastrointestinal Disease and Signs and Symptoms, Digestive, run by AstraZeneca at 183 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 50 years
Conditions the study is for: Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia
What is being tested?: Esomeprazole
How many people: 1,200 participants
Where: 183 sitesin 13 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 50 years
All sexes
No healthy volunteers
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.
Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach).

Who cannot join

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

183 sites in 13 countries.

Country

City, postcode or hospital

183 sites in 13 countries

Canada39 sites

Research Site
Ajax, Ontario
Research Site
Bay Roberts, Newfoundland and Labrador
Research Site
Brampton, Ontario
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Burlington, Ontario
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Calgary, Alberta
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Charlesbourg, Quebec
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Charlottetown, Prince Edward Island
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Dorchester, Ontario
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Edmonton, Alberta
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Elmsdale, Nova Scotia
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Granby, Quebec
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Halifax, Nova Scotia
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Hamilton, Ontario
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Kanata, Ontario
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Kelowna, British Columbia
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Kitchener, Ontario
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London, Ontario
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Markham, Ontario
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Mississauga, Ontario
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Niagara Falls, Ontario
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North York, Ontario
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Orléans, Ontario
Research Site
Oshawa, Ontario
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Ottawa, Ontario
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Parkdale, Prince Edward Island
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Penticton, British Columbia
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Richmond Hill, Ontario
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Saint Catherines, Ontario
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Saint-Léonard, Quebec
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Sainte Gedeon-de-Beauce, Ontario
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Sainte-Foy, Quebec
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Scarborough Village, Ontario
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St. John's, Newfoundland and Labrador
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Stirling, Ontario
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Thunder Bay, Ontario
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Toronto, Ontario
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Tottenham, Ontario
Research Site
Whitby, Ontario
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Winnipeg, Manitoba

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Sweden24 sites

Research Site
Ängelholm
Research Site
Fritsla
Research Site
Gothenburg
Research Site
Halmstad
Research Site
Höganäs
Research Site
Ingelstad
Research Site
Jönköping
Research Site
Kalmar
Research Site
Kilafors
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Kristinehamn
Research Site
Kungsör
Research Site
Motala
Research Site
Munkedal
Research Site
Nässjö
Research Site
Norrtälje
Research Site
Rättvik
Research Site
Staffanstorp
Research Site
Sundsbruk
Research Site
Trollhättan
Research Site
Uddevalla
Research Site
Upplands Vasby
Research Site
Vällingby
Research Site
Västerås
Research Site
Vaxjo

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Belgium21 sites

Research Site
Ans
Research Site
Brussels (Uccle)
Research Site
Gozée
Research Site
Halle
Research Site
Kontich
Research Site
Kortenberg
Research Site
Kraainem
Research Site
Liège
Research Site
Linkebeek
Research Site
Massemen
Research Site
Moerkerke
Research Site
Natoye
Research Site
Oud-Heverlee
Research Site
Saint-Médard
Research Site
Soignies
Research Site
Waremme
Research Site
Wezembeek-Oppem
Research Site
Wingene
Research Site
Zoersel
Research Site
Zolder
Research Site
Zonhoven

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United Kingdom21 sites

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Audley
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Blackburn
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Blackpool
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Chesterfield
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Coventry
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Ely, Cambridgeshire
Research Site
Enfield
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Glasgow
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Hadleigh
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Harrow
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Irvine
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Mansfield
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Nottingham
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Royal Tunbridge Wells
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Sheffield
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Shrewsbury
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Slough
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Titchfield
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Tonbridge
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Watford
Research Site
Woking, Surrey

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Norway15 sites

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Bekkestua
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Bergen
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Hønefoss
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Lier
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Lysaker
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Moss
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Oslo
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Østerås
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Paradis
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Rådal
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Rykkin
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Sandefjord
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Skien
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Søgne
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Tvedestrand

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Austria10 sites

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Braunau am Inn
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Graz
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Krems
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Linz
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Saint Johann
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Salzburg
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Sankt Pölten
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Vienna
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Wiener Neustadt
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Zell am See

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France10 sites

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Angers
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Dambach-la-Ville
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Dijon
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La Seyne-sur-Mer
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Laxou
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Louviers
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Mont-de-Marsan
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Nancy
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Saint-Ouen
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Vieux-Condé

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Finland9 sites

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Espoo
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Helsinki
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Kouvola
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Lempäälä
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Pirkkala
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Pori
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Sahalahti
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Tampere
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Vääksy

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Switzerland9 sites

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Aarau
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Brittnau
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Egg Bei Zürich, Canton of Zurich
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Küttigen
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Schaffhausen
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Schönbühl-Urtenen, Canton of Bern
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Winterthur, Canton of Zurich
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Zurich, Canton of Zurich
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Zurich

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Hungary8 sites

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Budaörs
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Budapest
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Esztergom
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Hatvan
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Siófok
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Tát
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Zalaegerszeg

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South Africa8 sites

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Bloemfontein
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Boksburg
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Cape Town
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Durban
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Lenasia, Gauteng
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Lyttelton Manor
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Pretoria

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Mexico6 sites

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Culiacán
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Guadalajara
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León
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México, D.F
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Torreón

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Germany3 sites

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München
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About this study

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.

Conditions: Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia
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.

Dec 2002Jan 2005

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: 1,200 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00251992
Sponsor's protocol ID: SD-NED-0022
Other IDs: D9610C00022
Status last verified: Jan 2011
First submitted: 9 Nov 2005
Last updated: 24 Jan 2011
Results posted: No

Publications

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.
PubMed 21848799
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.
PubMed 17697200

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.
ClinicalTrials.gov ID: NCT00251992
Acronym / sponsor ID: SD-NED-0022
Conditions: Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,200 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (2 listed)

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 21848799van 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.
Derived from this study: PubMed 17697200van 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.

Related trials for Gastrointestinal Disease

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
RecruitingPhase 1/2
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Biliary Cancer, Bile Duct Cancer
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Active, not recruitingPhase 2
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer
Advanced Biliary Tract Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms

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

183 sites in 13 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 183 sites in 13 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 2 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 183 sites in Canada, Sweden, Belgium, United Kingdom, Norway and 8 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 NCT00251992, 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.