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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 in Subjects in the US Only

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00633412
First received: March 5, 2008
Last updated: June 9, 2009
Last verified: June 2009
History of Changes
  Purpose

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 for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.


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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of patients with no gastric ulcers after 8 weeks of treatment. [ Time Frame: Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions. ]

Secondary Outcome Measures:
  • The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N [ Time Frame: Assessments at Week 0, Week 4 and Week 8 ]
  • To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy. [ Time Frame: Assessments at Week 0, Week 4 and Week 8 ]

Estimated Enrollment: 400
Study Start Date: February 2001
Study Completion Date: March 2003
Arms Assigned Interventions
Experimental: 1
20mg Oral tablet daily
 Drug: Esomeprazole
20mg oral daily
Other Name: Nexium
Experimental: 2
40mg Oral tablet daily
 Drug: Esomeprazole
40mg oral tablet daily
Other Name: Nexium
Active Comparator: 3
150mg oral twice daily
 Drug: Ranitidine
150mg oral twice daily
Other Name: Zantac

  Eligibility

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

Inclusion Criteria:

  • A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
  • A gastric ulcer >= 5mm in diameter, but no ulcer >25 mm at its greatest diameter, at the baseline endoscopy.
  • Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

  • History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
  • History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
  • Many other conditions and criteria, as specified in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633412

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00633412     History of Changes
Other Study ID Numbers: SH-NEN-0005, D9617C00005
Study First Received: March 5, 2008
Last Updated: June 9, 2009
Health Authority: United States: Food and Drug Administration

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
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Ranitidine
Ranitidine bismuth citrate
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
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013