Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Phase 3

Completed

• Conditions: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago
• Interventions: Drug: Placebo; Drug: Esomeprazole

• Registration Number: NCT00542789
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Study Completion: 2009-02
• Results First Submitted: 2010-02-16
• Status Verified: 2010-05
• Results First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Results First Posted: 2010-05-28
• Last Update Posted: 2010-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

• Medical history of gastric and/or duodenal ulcer
• A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria

• Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
• History of esophageal, gastric or duodenal surgery
• Having severe liver disease or chronic renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	Esomeprazole	Esomeprazole 20 mg

Primary Outcome Measures

Name	Time	Method
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period	each visit up to 24 weeks	The absence of gastric and/or duodenal ulcer throughout the treatment period

Secondary Outcome Measures

Name	Time	Method
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment	up to 4 weeks	The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment	up to 12 weeks	The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment

Trial Locations

Locations (1)

Research Site; 🇯🇵 Shizuoka, Japan