Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Gastric Ulcer

Eligibility:

All Genders

18-70 years

Phase:

PHASE3

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 pat...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

397 Patients enrolled

Trial Details

Trial ID

NCT00401752

Start Date

March 1 2006

End Date

November 1 2008

Last Update

July 8 2010

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Research Site

Fuzhou, Fujian, China

2

Research Site

Guangzhou, Guangdong, China

3

Research Site

Wuhan, Hubei, China

4

Research Site

Suzhou, Jiangsu, China