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| ID | Type | Description | Link |
|---|---|---|---|
| DIAMOND |
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The primary objective of this study is to determine the accuracy of the Reflux Disease Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by the RDQ will be compared with other established approaches to the diagnosis of gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms thought to be of upper gastrointestinal (GI) tract origin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | |||
| Bravo technique | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Selection of RDQ items (RDQ will be completed by subject at Screening and visit 4) | ||
| Presence/absence of GERD as assessed by endoscopic Los Angeles (LA) grade (gastroesophageal endoscopy will be performed at visit 2) | ||
| pH monitoring (% time with esophageal pH<4; Bravo pH-Monitoring will be performed from visit 2 to 3.1) | ||
| Symptom Associated Probability (outcome test for Bravo pH monitoring) | ||
| Outcome of PPI test (is assessed between visit 3.2 and 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean item score for the GSRS dimensions at the initial and last visit (as assessed by answers of patient at visit 1 and visit 4) | ||
| RDQ item scores and RDQ mean item scores for RDQ dimensions at baseline and at the end of treatment (as assessed by answers of patient at Screening and visit 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Nexium Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Etobicoke | Ontario | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25304129 | Derived | Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177. | |
| 22813439 | Derived |
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| Occurrence and severity of clinical symptoms at the initial and last visit (as reported by the subject) |
| Hamilton |
| Ontario |
| Canada |
| Research Site | North York | Ontario | Canada |
| Research Site | Mirabel | Quebec | Canada |
| Research Site | Pointe-Claire | Quebec | Canada |
| Research Site | Saint-Jérôme | Quebec | Canada |
| Research Site | Saint-Léonard | Quebec | Canada |
| Research Site | Glostrup Municipality | Denmark |
| Research Site | Herning | Denmark |
| Research Site | Odense | Denmark |
| Research Site | Randers | Denmark |
| Research Site | Berlin | Germany |
| Research Site | Bochum | Germany |
| Research Site | Dresden | Germany |
| Research Site | Garmisch-Partenkirchen | Germany |
| Research Site | Halle | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Mainz | Germany |
| Research Site | München | Germany |
| Research Site | Münster | Germany |
| Research Site | Siegen | Germany |
| Research Site | Bergen | Norway |
| Research Site | Gothenburg | Västra Götaland County | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Skövde | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Bicester | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | West Bromwich | United Kingdom |
| Bytzer P, Jones R, Vakil N, Junghard O, Lind T, Wernersson B, Dent J. Limited ability of the proton-pump inhibitor test to identify patients with gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1360-6. doi: 10.1016/j.cgh.2012.06.030. Epub 2012 Jul 17. |
| 20551454 | Derived | Dent J, Vakil N, Jones R, Bytzer P, Schoning U, Halling K, Junghard O, Lind T. Accuracy of the diagnosis of GORD by questionnaire, physicians and a trial of proton pump inhibitor treatment: the Diamond Study. Gut. 2010 Jun;59(6):714-21. doi: 10.1136/gut.2009.200063. |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| 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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