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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241553
First Posted: October 19, 2005
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
NSAIDs Upper GI Symptoms Drug: Esomeprazole Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 276
Study Start Date: April 2001
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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


  Show 137 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

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 Submitted: October 18, 2005
First Posted: October 19, 2005
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