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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595517
• Other study ID #: D961HC00005
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2008
• Last updated: August 20, 2012
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Duodenal Ulcer
• Gastric Ulcer
• Lumbago
• Osteoarthritis
• Rheumatoid Arthritis
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Esomeprazole 20 mg
Esomeprazole 20 mg once daily

Locations

Country	Name	City	State
Japan	Research Site	Oita
Japan	Research Site	Saitama
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period		up to 52 weeks	No
Secondary	Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment		up to 4 weeks after treatment	No
Secondary	Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment		up to 12 weeks after treatment	No
Secondary	Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment		up to 24 weeks after treatment	No