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A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00633672
First received: February 27, 2008
Last updated: January 24, 2011
Last verified: January 2011
History of Changes

February 27, 2008
January 24, 2011
February 2001
October 2003   (final data collection date for primary outcome measure)
To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
Same as current
Complete list of historical versions of study NCT00633672 on ClinicalTrials.gov Archive Site
  • Patient and investigator assessed GI symptoms for up to 8 weeks of treatment. [ Time Frame: Assessments at week 0, week 4 and week 8 ]
  • Safety and tolerability of the treatments for 8 weeks of treatment. [ Time Frame: Assessments at week 0, week 4 and week 8 ]
Same as current
Not Provided
Not Provided
 
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
NSAID Associated Gastric Ulcers
  • Drug: Esomeprazole
    20mg Oral tablet once daily
    Other Name: Nexium
  • Drug: Ranitidine
    150mg oral twice daily
    Other Name: Zantac
  • Drug: Esomeprazole
    40mg oral tablet once daily
    Other Name: Nexium
  • Experimental: 1
    20mg Oral tablet daily
    Intervention: Drug: Esomeprazole
  • Experimental: 2
    40mg oral tablet daily
    Intervention: Drug: Esomeprazole
  • Active Comparator: 3
    150mg oral twice daily
    Intervention: Drug: Ranitidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
October 2003
October 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
  2. Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

  1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
  2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
  3. Other conditions and criteria, as specified in the protocol.
Not Provided
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00633672
SH-NEN-0006
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
AstraZeneca
January 2011

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