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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
  Purpose

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.


Condition Intervention Phase
NSAID Associated Gastric Ulcers
 Drug: Esomeprazole
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

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 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 504
Study Start Date: March 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
20mg oral daily
 Drug: Esomeprazole
20mg oral daily
Other Name: Nexium
Experimental: 2
40mg oral daily
 Drug: Esomeprazole
40mg oral daily
Other Name: Nexium
Placebo Comparator: 3 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629512

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Professor Chris Hawkey Queens Medical Centre
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00629512     History of Changes
Other Study ID Numbers: SH-NEN-0013
Study First Received: February 27, 2008
Last Updated: March 12, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Ministry of Health
Brazil: National Health Surveillance Agency
Canada: Health Canada
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health
Norway: Directorate of Health
Poland: Ministry of Science and Higher Education
Sweden: Medical Products Agency
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
United States of America: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
NSAID, Nexium, esomeprazole, Gastric Ulcers

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
 Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013