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.

First Received: February 27, 2008 Last Updated: March 11, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00633672

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: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

Condition	Intervention	Phase
NSAID Associated Gastric Ulcers	Drug: Esomeprazole Drug: Ranitidine	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Ranitidine Ranitidine Hydrochloride Omeprazole Omeprazole magnesium Ranitidine bismuth citrate Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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 ]

Estimated Enrollment:	400
Study Start Date:	February 2001
Study Completion Date:	June 2003
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 20mg Oral tablet daily	Drug: Esomeprazole 20mg Oral tablet once daily
2: Experimental 40mg oral tablet daily	Drug: Esomeprazole 40mg oral tablet once daily
3: Active Comparator 150mg oral twice daily	Drug: Ranitidine 150mg oral twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
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.
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.
Other conditions and criteria, as specified in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633672

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Study ID Numbers:	SH-NEN-0006
Study First Received:	February 27, 2008
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00633672 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

NSAID
Nexium
esomeprazole
Gastric Ulcers

Study placed in the following topic categories:

Stomach Ulcer
Anti-Inflammatory Agents
Neurotransmitter Agents
Bismuth tripotassium dicitrate
Gastrointestinal Diseases
Ulcer
Citric Acid
Omeprazole
Histamine H2 Antagonists
Histamine
Bismuth
Ranitidine

Digestive System Diseases
Stomach Diseases
Histamine Antagonists
Ranitidine bismuth citrate
Analgesics, Non-Narcotic
Citrate
Histamine phosphate
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Peptic Ulcer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Omeprazole
Pathologic Processes
Stomach Diseases
Ranitidine bismuth citrate
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Peptic Ulcer
Stomach Ulcer
Ulcer
Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Pharmacologic Actions
Histamine H2 Antagonists
Ranitidine
Digestive System Diseases
Histamine Antagonists
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 02, 2009