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The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of pain or discomfort in the chest during the last week of the 4-week treatment course. | ||
| Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom response during the first week is based on diary cards, days 3-7. | ||
| The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week. | ||
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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 | Calgary | Alberta | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30992071 | Derived | Wade D, Cooper J, Derry F, Taylor J. Uro-Vaxom(R) versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study. Trials. 2019 Apr 16;20(1):223. doi: 10.1186/s13063-019-3275-x. | |
| 23147520 | Derived |
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| Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation. |
| Adverse events, clinical laboratory variables and vital signs. |
| Edmonton |
| Alberta |
| Canada |
| Research Site | Penticton | British Columbia | Canada |
| Research Site | Winkler | Manitoba | Canada |
| Research Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Burlington | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | North York | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Windsor | Ontario | Canada |
| Research Site | Charlottetown | Prince Edward Island | Canada |
| Research Site | Saint-Léonard | Quebec | Canada |
| Research Site | Saskatoon | Saskatchewan | Canada |
| Research Site | Charlottenlund | Denmark |
| Research Site | Elsinore | Denmark |
| Research Site | Esbjerg | Denmark |
| Research Site | Frederiksberg | Denmark |
| Research Site | Frederikssund | Denmark |
| Research Site | Herning | Denmark |
| Research Site | Hillerød | Denmark |
| Research Site | Kolding | Denmark |
| Research Site | København K | Denmark |
| Research Site | København NV | Denmark |
| Research Site | Odense | Denmark |
| Research Site | Odense C | Denmark |
| Research Site | Randers | Denmark |
| Research Site | Vejle | Denmark |
| Research Site | Stuttgart | Baden-Wurttemberg | Germany |
| Research Site | Augsburg | Bavaria | Germany |
| Research Site | Hanover | Lower Saxony | Germany |
| Research Site | Saarbrücken | Saarland | Germany |
| Research Site | Dresden | Saxony | Germany |
| Research Site | Halle | Saxony-Anhalt | Germany |
| Research Site | Bad Segeberg | Schleswig-Holstein | Germany |
| Research Site | Berlin | State of Berlin | Germany |
| Research Site | Augsburg | Germany |
| Research Site | Bad Segeberg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Chemnitz | Germany |
| Research Site | Dillingen | Germany |
| Research Site | Dresden | Germany |
| Research Site | Görlitz | Germany |
| Research Site | Hermaringen | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Löbau | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Münster | Germany |
| Research Site | Weener | Germany |
| Research Site | Wolmirstedt | Germany |
| Research Site | Lichtenvoorde | Gelderland | Netherlands |
| Research Site | Deurne | North Brabant | Netherlands |
| Research Site | Oldebroek | Overijssel | Netherlands |
| Research Site | Hoogvliet | South Holland | Netherlands |
| Research Site | Rijswijk | South Holland | Netherlands |
| Research Site | Roelofarendsveen | South Holland | Netherlands |
| Research Site | Rotterdam | South Holland | Netherlands |
| Research Site | 's-Hertogenbosch | Netherlands |
| Research Site | Beek en Donk | Netherlands |
| Research Site | Hoogwoud | Netherlands |
| Research Site | Huizen | Netherlands |
| Research Site | Nijverdal | Netherlands |
| Research Site | Spijkenisse | Netherlands |
| Research Site | Tilburg | Netherlands |
| Research Site | Bergen | Norway |
| Research Site | Gjøvik | Norway |
| Research Site | Hønefoss | Norway |
| Research Site | Nestun | Norway |
| Research Site | Oslo | Norway |
| Research Site | Skedsmokorset | Norway |
| Research Site | Åkersberga | Sweden |
| Research Site | Gothenburg | Sweden |
| Research Site | Krokom | Sweden |
| Research Site | Norrtälje | Sweden |
| Research Site | Östersund | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Trollhättan | Sweden |
| Research Site | Umeå | Sweden |
| Flook NW, Moayyedi P, Dent J, Talley NJ, Persson T, Karlson BW, Ruth M. Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2013 Jan;108(1):56-64. doi: 10.1038/ajg.2012.369. Epub 2012 Nov 13. |
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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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