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| ID | Type | Description | Link |
|---|---|---|---|
| D9610C00021 |
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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 | Buenos Aires | Argentina | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19577008 | Derived | 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. | |
| 17697201 | Derived |
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| Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy |
| Mendoza |
| Argentina |
| Research Site | Rosario | Argentina |
| Research Site | San Miguel de Tucumán | Argentina |
| Research Site | Santa Fe | Argentina |
| Research Site | Aalst | Belgium |
| Research Site | Andenne | Belgium |
| Research Site | Bonheiden | Belgium |
| Research Site | Bruges | 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 | Belgium |
| Research Site | Rio de Janeiro | Rio de Janeiro | 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 | Salvador | Brazil |
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| Research Site | Edmonton | Alberta | Canada |
| Research Site | Coquitlam | British Columbia | Canada |
| Research Site | Langley | British Columbia | Canada |
| Research Site | Vancouver | British Columbia | Canada |
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| Research Site | Trondheim | Norway |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Târgu Mureş | Romania |
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| Research Site | Singapore | Singapore |
| 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 | South Africa |
| Research Site | Santiago | A Coruña | Spain |
| Research Site | Santiago de Compostela | A Coruña | Spain |
| Research Site | Barcelona | Barcelona | Spain |
| Research Site | Viladecans | Barcelona | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Seville | Sevilla | Spain |
| Research Site | Arbrå | Sweden |
| Research Site | Ängelholm | Sweden |
| Research Site | Gothenburg | 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 Vasby | Sweden |
| Research Site | Varberg | Sweden |
| Research Site | Värnamo | Sweden |
| Research Site | Västerås | Sweden |
| Research Site | Baden | Canton of Aargau | Switzerland |
| Research Site | Frick | Canton of Aargau | Switzerland |
| Research Site | Spreitenbach | Canton of Zurich | Switzerland |
| Research Site | Basel | Switzerland |
| Research Site | Ennetbaden | Switzerland |
| Research Site | Sankt Gallen | Switzerland |
| Research Site | Sargans | Switzerland |
| Talley 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. |
| 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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