GERD Clinical Trial
Official title:
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is 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 period of 4 weeks in treatment of relief of upper GI symptoms.
| Status | Completed |
| Enrollment | 808 |
| Est. completion date | August 2002 |
| Est. primary completion date | August 2002 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years of age, or older. - Capable of completing the diary card. - Ability to complete the HRQL questionnaires. - A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. - Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day). - Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally). Exclusion Criteria: - Current, or history of, gastric or duodenal ulcer - Current, or history of, esophageal, gastric or duodenal surgery. - History of GERD, not associated with NSAID use. - Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation. - Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator. - Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Alleur | |
| Belgium | Research Site | Ans | |
| Belgium | Research Site | Beernem | |
| Belgium | Research Site | Betekom | |
| Belgium | Research Site | Bottelaere | |
| Belgium | Research Site | Braine-L 'Alleud | |
| Belgium | Research Site | Brussels (Ixelles) | |
| Belgium | Research Site | Brussels (Jette) | |
| Belgium | Research Site | Brussels (Uccle) | |
| Belgium | Research Site | Buizingen | |
| Belgium | Research Site | Duffel | |
| Belgium | Research Site | Durnal | |
| Belgium | Research Site | Erembodegem | |
| Belgium | Research Site | Forest | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Halle | |
| 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 | Uccle | |
| Belgium | Research Site | Vorst (Brussels) | |
| Belgium | Research Site | Waremme | |
| Belgium | Research Site | Zoersel | |
| Belgium | Research Site | Zolder | |
| France | Research Site | Albens | |
| France | Research Site | Angers | |
| France | Research Site | Dambach La Ville | |
| France | Research Site | Dommartin-les-touls | |
| France | Research Site | Fontaine Les Dijon | |
| France | Research Site | Gemenos | |
| France | Research Site | Geste | |
| France | Research Site | Husseren-wesserling | |
| France | Research Site | La Regrip | |
| France | Research Site | Le Pian Medoc | |
| France | Research Site | Lille | |
| France | Research Site | Lyon | |
| France | Research Site | Maromme | |
| France | Research Site | MONT DE MARSAN Cedex | |
| France | Research Site | Montingy Les Metz | |
| France | Research Site | Paris | |
| France | Research Site | Saint-ouen | |
| France | Research Site | Strasbourg | |
| France | Research Site | Tarare | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bernau | |
| Germany | Research Site | Bochum | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Erfurt | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Genthin | |
| Germany | Research Site | Herne | |
| Germany | Research Site | Kelkheim | |
| Germany | Research Site | Köln | |
| 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 | Stockach | |
| Germany | Research Site | Wangen | |
| Germany | Research Site | Wiesbaden | |
| Germany | Research Site | Wolmirstedt | |
| Hungary | 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 | |
| Spain | 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 | Sevilla | |
| Spain | Research Site | Torrelavega | |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Viladecans | |
| Spain | Research Site | Zaragoza | |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bradenton | Florida |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Conyers | Georgia |
| United States | Research Site | Ft. Lauderdale | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Newburgh | Indiana |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Orange | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | South Miami | Florida |
| United States | Research Site | Tipton | Pennsylvania |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Virginia Beach | Virginia |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Zephyr Hills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Belgium, France, Germany, Hungary, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation | |||
| Secondary | - To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy | |||
| Secondary | - To assess the impact of treatment |
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