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 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 27, 2008

Last Updated Date

March 11, 2008

Start Date ^ICMJE

February 2001

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00633672 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

NSAID Associated Gastric Ulcers

Intervention ^ICMJE

Drug: Esomeprazole
Drug: Ranitidine

Study Arms / Comparison Groups

Experimental: 20mg Oral tablet daily
Experimental: 40mg oral tablet daily
Active Comparator: 150mg oral twice daily

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

400

Completion Date

June 2003

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00633672

Responsible Party

Study ID Numbers ^ICMJE

SH-NEN-0006

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP