Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

Phase 3

Completed

• Conditions: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago
• Interventions: Drug: Esomeprazole 20 mg

• Registration Number: NCT00595517
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-08-04
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-20
• Last Update Submitted: 2012-08-20
• Results First Posted: 2012-09-14
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esomeprazole 20 mg	Esomeprazole 20 mg	Esomeprazole 20 mg once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period	up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment	up to 4 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment	up to 12 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment	up to 24 weeks after treatment

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan