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| ID | Type | Description | Link |
|---|---|---|---|
| D9610C00022 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Nexium Medical Sciences Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Braunau am Inn | Austria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21848799 | Derived | 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. | |
| 17697200 |
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| Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy |
| Graz |
| Austria |
| Research Site | Krems | Austria |
| Research Site | Linz | Austria |
| Research Site | Saint Johann | Austria |
| Research Site | Salzburg | Austria |
| Research Site | Sankt Pölten | Austria |
| Research Site | Vienna | Austria |
| Research Site | Wiener Neustadt | Austria |
| Research Site | Zell am See | Austria |
| 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 | Belgium |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Kelowna | British Columbia | Canada |
| Research Site | Penticton | British Columbia | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Bay Roberts | Newfoundland and Labrador | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Elmsdale | Nova Scotia | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Ajax | Ontario | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Burlington | Ontario | Canada |
| Research Site | Dorchester | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Kanata | Ontario | 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 | Orléans | Ontario | Canada |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Richmond Hill | Ontario | Canada |
| Research Site | Saint Catherines | Ontario | Canada |
| Research Site | Sainte Gedeon-de-Beauce | Ontario | Canada |
| Research Site | Scarborough Village | Ontario | 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 | Charlottetown | Prince Edward Island | Canada |
| Research Site | Parkdale | Prince Edward Island | Canada |
| Research Site | Charlesbourg | Quebec | Canada |
| Research Site | Granby | Quebec | Canada |
| Research Site | Saint-Léonard | Quebec | Canada |
| Research Site | Sainte-Foy | Quebec | Canada |
| 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 | Finland |
| 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 | France |
| Research Site | Nancy | France |
| Research Site | Saint-Ouen | France |
| Research Site | Vieux-Condé | France |
| Research Site | Lochham | Germany |
| Research Site | München | Germany |
| Research Site | Rödental | Germany |
| 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 | Hungary |
| Research Site | México | D.F | Mexico |
| Research Site | Culiacán | Mexico |
| Research Site | Guadalajara | Mexico |
| Research Site | León | Mexico |
| Research Site | México | Mexico |
| Research Site | Torreón | Mexico |
| 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 | Paradis | Norway |
| Research Site | Rådal | Norway |
| Research Site | Rykkin | Norway |
| Research Site | Sandefjord | Norway |
| Research Site | Skien | Norway |
| Research Site | Søgne | Norway |
| Research Site | Tvedestrand | Norway |
| Research Site | Østerås | Norway |
| Research Site | Lenasia | Gauteng | 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 | Lyttelton Manor | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Ängelholm | Sweden |
| Research Site | Fritsla | Sweden |
| Research Site | Gothenburg | 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 Vasby | Sweden |
| Research Site | Vaxjo | Sweden |
| Research Site | Vällingby | Sweden |
| Research Site | Västerås | Sweden |
| Research Site | Schönbühl-Urtenen | Canton of Bern | Switzerland |
| Research Site | Egg Bei Zürich | Canton of Zurich | Switzerland |
| Research Site | Winterthur | Canton of Zurich | Switzerland |
| Research Site | Zurich | Canton of Zurich | Switzerland |
| Research Site | Aarau | Switzerland |
| Research Site | Brittnau | Switzerland |
| Research Site | Küttigen | Switzerland |
| Research Site | Schaffhausen | Switzerland |
| Research Site | Zurich | Switzerland |
| Research Site | Ely | Cambridgeshire | United Kingdom |
| Research Site | Woking | Surrey | 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 | 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 | Royal Tunbridge Wells | 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 | Watford | United Kingdom |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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