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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

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ClinicalTrials.gov Identifier: NCT00633672
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NSAID Associated Gastric Ulcers Drug: Esomeprazole Drug: Ranitidine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
20mg Oral tablet daily
 Drug: Esomeprazole
20mg Oral tablet once daily
Other Name: Nexium
Experimental: 2
40mg oral tablet daily
 Drug: Esomeprazole
40mg oral tablet once daily
Other Name: Nexium
Active Comparator: 3
150mg oral twice daily
 Drug: Ranitidine
150mg oral twice daily
Other Name: Zantac


Outcome Measures
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Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Patient and investigator assessed GI symptoms for up to 8 weeks of treatment. [ Time Frame: Assessments at week 0, week 4 and week 8 ]
  2. Safety and tolerability of the treatments for 8 weeks of treatment. [ Time Frame: Assessments at week 0, week 4 and week 8 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00633672


Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
More Information
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ClinicalTrials.gov Identifier: NCT00633672    
Other Study ID Numbers: SH-NEN-0006
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
NSAID
Nexium
esomeprazole
Gastric Ulcers
Additional relevant MeSH terms:
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Stomach Ulcer
Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Ranitidine
 Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs