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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241540
First received: October 18, 2005
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
GERD
Drug: Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • - 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

Estimated Enrollment: 808
Study Start Date: January 2001
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241540

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Locations
United States, Arizona
Research Site
Tucson, Arizona, United States
United States, California
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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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Brussels (Ixelles), Belgium
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France
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Geste, France
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La Regrip, France
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Le Pian Medoc, 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 Cedex, France
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Montingy Les Metz, France
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Paris, France
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Strasbourg, France
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Tarare, France
Germany
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Berlin, Germany
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Bernau, Germany
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Bochum, 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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Lienen, Germany
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Ratingen, 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
Hungary
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Budapest, Hungary
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Békéscsaba, Hungary
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Dunaújváros, Hungary
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Szentes, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Vác, Hungary
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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Sevilla, 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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00241540     History of Changes
Other Study ID Numbers: D9617C00001, SH-NEN-0001
Study First Received: October 18, 2005
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
NSAIDs
Upper GI symptoms

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014