Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Primary Purpose
Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Esomeprazole 20 mg
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Ulcer focused on measuring gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esomeprazole 20 mg
Arm Description
Esomeprazole 20 mg once daily
Outcomes
Primary Outcome Measures
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Secondary Outcome Measures
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00595517
Brief Title
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Official Title
A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
Keywords
gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
395 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole 20 mg
Arm Type
Experimental
Arm Description
Esomeprazole 20 mg once daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20 mg
Intervention Description
Esomeprazole 20 mg once daily
Primary Outcome Measure Information:
Title
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time Frame
up to 52 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time Frame
up to 4 weeks after treatment
Title
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time Frame
up to 12 weeks after treatment
Title
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Time Frame
up to 24 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naotsugu Oyama
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Saitama
Country
Japan
Facility Name
Research Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23530709
Citation
Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.
Results Reference
derived
Learn more about this trial
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
We'll reach out to this number within 24 hrs