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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241553
First received: October 18, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  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
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 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241553

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

No publications provided by AstraZeneca

Additional 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
Study First Received: October 18, 2005
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Digestive System Diseases
Signs and Symptoms
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 May 21, 2013