Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-Induced Gastric Ulcer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 17, 2006

Last Updated Date

March 11, 2009

Start Date ^†

March 2006

Current Primary Outcome Measures ^†

Assess the efficacy of esomeprazole 20 mg qd through 4 weeks of treatment in these patients

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00401752 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Assess the efficacy of esomeprazole 20 mg qd through 8 weeks of treatment in these patients.
Evaluate the patient symptoms for up to 8 weeks of treatment in these patients.
Evaluate the safety and tolerability for up to 8 weeks of treatment in these patients.

Original Secondary Outcome Measures ^†

Assess the efficacy of esomeprazole 20 mg qd through 8 weeks of treatment in these patients.
Evaluate the patient symptoms for up to 8 weeks of treatment in these patients.
Evaluate the safety and tolerability for up to 8 weeks of treatment in these patients.

Descriptive Information

Brief Title ^†

Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-Induced Gastric Ulcer

Official Title ^†

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg qd Versus Ranitidine 150 mg Bid in Patients With an NSAID-Associated Gastric Ulcer When Daily NSAID is Continued

Brief Summary

The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Gastric Ulcer

Intervention ^†

Drug: Esomeprazole
Drug: Ranitidine

Study Arms / Comparison Groups

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 ^†

Completed

Enrollment ^†

320

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Signed informed consent.
A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months.
Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally;

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

China, Hong Kong

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00401752

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

Tore Lind, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.