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

Last updated: June 10, 2010
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Ulcers

Stomach Discomfort

Colic

Treatment

N/A

Clinical Study ID

NCT00401752
D9617L00001
  • Ages 18-70
  • All Genders

Study 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 non-steroidal anti-inflammatory drug (NSAID)therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent.

  • A clinical diagnosis of a chronic condition that requires daily NSAID treatment for atleast 2 months.

  • Daily NSAID dose and type must have been stable for at least 2 weeks prior to thebaseline endoscopy;orally;

Exclusion

Exclusion Criteria:

  • History of esophageal, gastric or duodenal surgery, except for simple closure of anulcer.

  • History of severe liver disease, including (but not limited to) cirrhosis and acute orchronic hepatitis.

Study Design

Total Participants: 397
Study Start date:
March 01, 2006
Estimated Completion Date:
November 30, 2008

Connect with a study center

  • Research Site

    Fuzhou, Fujian
    China

    Site Not Available

  • Research Site

    Guangzhou, Guangdong
    China

    Site Not Available

  • Research Site

    Wuhan, Hubei
    China

    Site Not Available

  • Research Site

    Suzhou, Jiangsu
    China

    Site Not Available

  • Research Site

    Shenyang, Liaoning
    China

    Site Not Available

  • Research Site

    Xi'an, Shanxi
    China

    Site Not Available

  • Research Site

    Beijing,
    China

    Site Not Available

  • Research Site

    Shanghai,
    China

    Site Not Available

  • Research Site

    Hong Kong,
    Hong Kong

    Site Not Available

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