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 Every Day (qd) Versus Ranitidine 150 mg Twice a Day (Bid) in Patients With an NSAID-associated Gastric Ulcer When Daily NSAID is Continued”

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.

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
• Drug: Ranitidine

Primary Measures

• The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
  • Time Frame: 8 weeks
    Safety Issue?: No
• The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
  • Time Frame: week 4 and week 8
    Safety Issue?: No
• Percentage of Participants With the Occurance of Any Adverse Event.
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
  • Time Frame: 4 and 8 week
    Safety Issue?: No
• The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy
  • Time Frame: 4 & 8 weeks
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Tore Lind, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00401752

Study ID Number: D9617L00001

ClinicalTrials.gov Identifier: NCT00401752

Health Authority: China: State Food and Drug Administration