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Prevention of Gastric Ulcers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00629512
First received: February 27, 2008
Last updated: March 12, 2009
Last verified: March 2009
History of Changes

February 27, 2008
March 12, 2009
March 2001
December 2002   (final data collection date for primary outcome measure)
To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]
Same as current
Complete list of historical versions of study NCT00629512 on ClinicalTrials.gov Archive Site
  • Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy. [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]
  • Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]
Same as current
Not Provided
Not Provided
 
Prevention of Gastric Ulcers
A Comparative Efficacy and Safety Study of Nexium (Esomeprazole Magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated With Daily NSAID Use in Patients at Risk

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
NSAID Associated Gastric Ulcers
  • Drug: Esomeprazole
    20mg oral daily
    Other Name: Nexium
  • Drug: Esomeprazole
    40mg oral daily
    Other Name: Nexium
  • Drug: Placebo
  • Experimental: 1
    20mg oral daily
    Intervention: Drug: Esomeprazole
  • Experimental: 2
    40mg oral daily
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
504
December 2002
December 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. No gastric or duodenal ulcer on baseline endoscopy.
  2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
  3. Other inclusion criteria, as defined in the protocol.

Exclusion Criteria:

  1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
  2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
  3. Other criteria, as defined in the protocol.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00629512
SH-NEN-0013
Not Provided
Not Provided
AstraZeneca
Not Provided
Principal Investigator: Professor Chris Hawkey Queens Medical Centre
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP