Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

NCT00241540 | Completed Phase 3

• 2 other identifiers: D9617C00001SH-NEN-0001
• Study Type: interventional
• Target: 808
• Locations: 6 countries
• Sites: 119

Brief Summary

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.

Conditions

GERD

Keywords

NSAIDs; Upper GI symptoms

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation

Secondary Outcomes (2)

• - To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy

• - To assess the impact of treatment

Interventions

Esomeprazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (119)

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Tucson, Arizona, United States

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Anaheim, California, United States

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Orange, California, United States

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San Francisco, California, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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South Miami, Florida, United States

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West Palm Beach, Florida, United States

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Zephyrhills, Florida, United States

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Conyers, Georgia, United States

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Newburgh, Indiana, United States

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Baltimore, Maryland, United States

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Winston-Salem, North Carolina, United States

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Tulsa, Oklahoma, United States

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Tipton, Pennsylvania, United States

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Norfolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Alleur, Belgium

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Ans, Belgium

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Beernem, Belgium

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Betekom, Belgium

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Bottelare, Belgium

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Braine-l'Alleud, Belgium

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Brussels (Ixelles), Belgium

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Brussels (Jette), Belgium

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Brussels (Uccle), Belgium

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Buizingen, Belgium

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Duffel, Belgium

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Durnal, Belgium

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Erembodegem, Belgium

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Forest, Belgium

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Genk, Belgium

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Ghent, Belgium

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Halle, Belgium

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Herentals, Belgium

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Lambermont, Belgium

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Leut, Belgium

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Liège, Belgium

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Linkebeek, Belgium

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Maasmechelen, Belgium

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Massemen, Belgium

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Merelbeke, Belgium

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Natoye, Belgium

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Nivelles, Belgium

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Oud-Heverlee, Belgium

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Seraing, Belgium

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Soignies, Belgium

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Uccle, Belgium

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Vorst (Brussels), Belgium

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Waremme, Belgium

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Zoersel, Belgium

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Zolder, Belgium

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Albens, France

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Angers, France

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Dambach-la-Ville, France

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Dommartin-les-touls, France

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Fontaine-lès-Dijon, France

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Gesté, France

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Gémenos, France

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Husseren-Wesserling, France

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La Regrip, France

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Le Pian-Médoc, France

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Lille, France

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Lyon, France

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Maromme, France

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Mont-de-Marsan, France

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Montingy Les Metz, France

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Paris, France

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Saint-Ouen, France

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Strasbourg, France

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Tarare, France

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Berlin, Germany

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Bernau, Germany

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Bochum, Germany

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Cologne, Germany

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Dresden, Germany

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Erfurt, Germany

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Erlangen, Germany

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Genthin, Germany

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Herne, Germany

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Kelkheim, Germany

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Künzing, Germany

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Lienen, Germany

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Lüdenscheid, Germany

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München, Germany

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Münster, Germany

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Paderborn, Germany

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Passau, Germany

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Potsdam, Germany

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Ratingen, Germany

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Regensburg, Germany

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Ribnitz-Damgarten, Germany

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Saarbrücken, Germany

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Salzgitter, Germany

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Stockach, Germany

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Wangen, Germany

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Wiesbaden, Germany

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Wolmirstedt, Germany

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Békéscsaba, Hungary

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Budapest, Hungary

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Dunaújváros, Hungary

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Szentes, Hungary

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Szombathely, Hungary

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Vác, Hungary

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Veszprém, Hungary

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Barcelona, Spain

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Getafe, Spain

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Guadalajara, Spain

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Madrid, Spain

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Mérida, Spain

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Palma de Mallorca, Spain

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San Sebastián(Guipuzcoa), Spain

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Seville, Spain

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Torrelavega, Spain

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Valencia, Spain

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Viladecans, Spain

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Zaragoza, Spain

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MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• AstraZeneca Nexium Medical Sciences Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2005
• First Posted: October 19, 2005
• Study Start: January 1, 2001
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: January 24, 2011

Record last verified: 2011-01

Locations

ES (12); BE (35); FR (19); US (19); DE (27); HU (7)