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

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ClinicalTrials.gov Identifier: NCT00241553
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 theefficacy 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.

Condition or disease Intervention/treatment Phase
NSAIDs Upper GI Symptoms Drug: Esomeprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs
Study Start Date : April 2001
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

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U.S. FDA Resources




Primary Outcome Measures :
  1. To assess the efficacy of esomeprazole versus placebo through 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use

Secondary Outcome Measures :
  1. To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
  • A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
  • Daily NSAID treatment dose and type:
  • Must have been stable for at least 9 weeks prior to inclusion
  • Are expected to remain stable for the duration of the study.
  • Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally.
  • Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.

Exclusion Criteria:

  • Discontinuation from study SH-NEN-0003
  • 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.
  • Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241553


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00241553     History of Changes
Other Study ID Numbers: D9617C00004
SH-NEN-0004
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action