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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014