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| ID | Type | Description | Link |
|---|---|---|---|
| SH-NEN-0002 |
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This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d. | ||
| and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the | ||
| prevention of relapse of upper GI symptom associated with NSAID use in patients | ||
| receiving daily NSAID therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy. |
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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 | Tucson | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17391505 | Derived | Hawkey CJ, Talley NJ, Scheiman JM, Jones RH, Langstrom G, Naesdal J, Yeomans ND; NASA/SPACE author group. Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies. Arthritis Res Ther. 2007;9(1):R17. doi: 10.1186/ar2124. |
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| Anaheim |
| California |
| United States |
| Research Site | Orange | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Clearwater | Florida | United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | South Miami | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Zephyrhills | Florida | United States |
| Research Site | Conyers | Georgia | United States |
| Research Site | Newburgh | Indiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Tulsa | Oklahoma | United States |
| Research Site | Tipton | Pennsylvania | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Alleur | Belgium |
| Research Site | Ans | Belgium |
| Research Site | Beernem | Belgium |
| Research Site | Betekom | Belgium |
| Research Site | Bottelare | Belgium |
| Research Site | Braine-l'Alleud | Belgium |
| Research Site | Buizingen | Belgium |
| Research Site | Duffel | Belgium |
| Research Site | Durnal | Belgium |
| Research Site | Erembodegem | Belgium |
| Research Site | Genk | Belgium |
| Research Site | Ghent | Belgium |
| Research Site | Herentals | Belgium |
| Research Site | Lambermont | Belgium |
| Research Site | Leut | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Linkebeek | Belgium |
| Research Site | Maasmechelen | Belgium |
| Research Site | Massemen | Belgium |
| Research Site | Merelbeke | Belgium |
| Research Site | Natoye | Belgium |
| Research Site | Nivelles | Belgium |
| Research Site | Oud-Heverlee | Belgium |
| Research Site | Seraing | Belgium |
| Research Site | Soignies | Belgium |
| Research Site | Vorst (Brussels) | Belgium |
| Research Site | Waremme | Belgium |
| Research Site | Zoersel | Belgium |
| Research Site | Zolder | Belgium |
| Research Site | Albens | France |
| Research Site | Angers | France |
| Research Site | Dambach-la-Ville | France |
| Research Site | Dommartin-les-touls | France |
| Research Site | Fontaine-lès-Dijon | France |
| Research Site | Gesté | France |
| Research Site | Gémenos | France |
| Research Site | Husseren-Wesserling | France |
| Research Site | La Regrip | France |
| Research Site | Le Pian-Médoc | France |
| Research Site | Lille | France |
| Research Site | Lyon | France |
| Research Site | Maromme | France |
| Research Site | Mont-de-Marsan | France |
| Research Site | Montingy Les Metz | France |
| Research Site | Paris | France |
| Research Site | Saint-Ouen | France |
| Research Site | Strasbourg | France |
| Research Site | Tarare | France |
| Research Site | Berlin | Germany |
| Research Site | Bernau | Germany |
| Research Site | Bochum | Germany |
| Research Site | Cologne | Germany |
| Research Site | Dresden | Germany |
| Research Site | Dresden-Test | Germany |
| Research Site | Erfurt | Germany |
| Research Site | Erlangen | Germany |
| Research Site | Genthin | Germany |
| Research Site | Herne | Germany |
| Research Site | Kelkheim | Germany |
| Research Site | Künzing | Germany |
| Research Site | Lienen | Germany |
| Research Site | Lüdenscheid | Germany |
| Research Site | München | Germany |
| Research Site | Münster | Germany |
| Research Site | Paderborn | Germany |
| Research Site | Passau | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Ratingen | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Ribnitz-Damgarten | Germany |
| Research Site | Saarbrücken | Germany |
| Research Site | Salzgitter | Germany |
| Research Site | Wangen | Germany |
| Research Site | Wiesbaden | Germany |
| Research Site | Wolmirstedt | Germany |
| Research Site | Békéscsaba | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Dunaújváros | Hungary |
| Research Site | Szentes | Hungary |
| Research Site | Szombathely | Hungary |
| Research Site | Vác | Hungary |
| Research Site | Veszprém | Hungary |
| Research Site | Barcelona | Spain |
| Research Site | Getafe | Spain |
| Research Site | Guadalajara | Spain |
| Research Site | Madrid | Spain |
| Research Site | Mérida | Spain |
| Research Site | Palma de Mallorca | Spain |
| Research Site | San Sebastián(Guipuzcoa) | Spain |
| Research Site | Seville | Spain |
| Research Site | Torrelavega | Spain |
| Research Site | Valencia | Spain |
| Research Site | Viladecans | Spain |
| Research Site | Zaragoza | Spain |
| 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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