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| ID | Type | Description | Link |
|---|---|---|---|
| SH-NEN-0003 |
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This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the upper GI symptoms (pain, discomfort or | ||
| burning in the upper abdomen), rated on a 7-graded severity scale |
| Measure | Description | Time Frame |
|---|---|---|
| - Mean change in the upper GI symptom score | ||
| - The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment. | ||
| - Mean upper GI symptom score by day over the duration of the study. |
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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 | Tallassee | Alabama | United States | |||
| Research Site |
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| - Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4. |
| - Proportions of patients with upper GI symptoms during night, over the duration of the study. |
| - The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits. |
| - The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS) |
| - Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems |
| - Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits. |
| -Short Form-36 (SF-36) score at baseline. |
| Phoenix |
| Arizona |
| United States |
| Research Site | Garden Grove | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Coral Gables | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | St. Petersburg | Florida | United States |
| Research Site | Tavares | Florida | United States |
| Research Site | Zephyrhills | Florida | United States |
| Research Site | Nampa | Idaho | United States |
| Research Site | Elkhart | Indiana | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Newburgh | Indiana | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Hollywood | Maryland | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Princeton | New Jersey | United States |
| Research Site | Toms River | New Jersey | United States |
| Research Site | Endwell | New York | United States |
| Research Site | Hewlett | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Duncansville | Pennsylvania | United States |
| Research Site | Erie | Pennsylvania | United States |
| Research Site | Jackson | Tennessee | United States |
| Research Site | Pasadena | Texas | United States |
| Research Site | Waco | Texas | United States |
| Research Site | Edmonds | Washington | United States |
| Research Site | Olympia | Washington | United States |
| Research Site | Greenfield | Wisconsin | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Five Dock | New South Wales | Australia |
| Research Site | Carina Heights | Queensland | Australia |
| Research Site | Kippa-Ring | Queensland | Australia |
| Research Site | Ivanhoe | Victoria | Australia |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Kitchener | Ontario | Canada |
| Research Site | Newmarket | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Windsor | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Sainte-Foy | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Saskatoon | Saskatchewan | Canada |
| Research Site | Quesnel | Canada |
| Research Site | St. John's | Canada |
| Research Site | Ostrava | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Bari | BA | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Milan | MI | Italy |
| Research Site | Perugia | PG | Italy |
| Research Site | Vicenza | VI | Italy |
| Research Site | Naples | Italy |
| Research Site | Verona | Italy |
| Research Site | Bergen | Norway |
| Research Site | Bodø | Norway |
| Research Site | Bærum Postterminal | Norway |
| Research Site | Gjøvik | Norway |
| Research Site | Horten | Norway |
| Research Site | Kristiansand | Norway |
| Research Site | Lillehammer | Norway |
| Research Site | Nesttun | Norway |
| Research Site | Oslo | Norway |
| Research Site | Sandvika | Norway |
| Research Site | Skien | Norway |
| Research Site | Stavanger | Norway |
| Research Site | Tromsø | Norway |
| Research Site | Bydgoszcz | Poland |
| Research Site | Sopot | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Bratislava | Slovakia |
| Research Site | Nové Mesto nad Váhom | Slovakia |
| Research Site | Bloemfontein | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Bredbyn | Sweden |
| Sweden | Gävle | Sweden |
| Research Site | Karlskrona | Sweden |
| Research Site | Kungälv | Sweden |
| Research Site | Lidköping | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Oskarshamn | Sweden |
| Research Site | Örnsköldsvik | Sweden |
| Research Site | Östersund | Sweden |
| Research Site | Rättvik | Sweden |
| Research Site | Skövde | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Trehörningsjö | Sweden |
| Research Site | Trollhättan | Sweden |
| Research Site | Varberg | Sweden |
| Research Site | Värnamo | Sweden |
| Research Site | Västervik | Sweden |
| Research Site | Reading | Berks | United Kingdom |
| Research Site | Spennymoor | Co. Durham | United Kingdom |
| Research Site | Woking | Surrey | United Kingdom |
| Research Site | Trowbridge | Wiltshire | United Kingdom |
| Research Site | Ashford | United Kingdom |
| Research Site | Audley | United Kingdom |
| Research Site | Bath | United Kingdom |
| Research Site | Bradford Upon Avon | United Kingdom |
| Research Site | Chesterfield | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Crawley | United Kingdom |
| Research Site | Ely | United Kingdom |
| Research Site | Folkestone | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Kilmarnock | United Kingdom |
| Research Site | Leigh | United Kingdom |
| Research Site | Mansfield | United Kingdom |
| Research Site | Nottingham | United Kingdom |
| Research Site | Pontefract | United Kingdom |
| Research Site | Royal Tunbridge Wells | United Kingdom |
| Research Site | Shrewsbury | United Kingdom |
| Research Site | Stafford | United Kingdom |
| Research Site | Swansea | United Kingdom |
| Research Site | Trowbridge | United Kingdom |
| Research Site | Watford | United Kingdom |
| Research Site | Wigston | United Kingdom |
| Research Site | Woking | United Kingdom |
| Research Site | Worsley | United Kingdom |
| Research Site | Yoxall | United Kingdom |
| 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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