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

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo 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: NCT00542789
• Other study ID #: D961HC00001
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2007
• Last updated: May 10, 2010
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: May 2010
• 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: February 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Esomeprazole
20mg once daily oral
• Placebo
once daily oral

Locations

Country	Name	City	State
Japan	Research Site	Akashi	HYOGOi
Japan	Research Site	Beppu	Oita
Japan	Research Site	Chiisagata	Nagano
Japan	Research Site	Chiryu	Aichi
Japan	Research Site	Chiyoda	Tokyo
Japan	Research Site	Fukuroi	Shizuoka
Japan	Research Site	Hamamatsu	Shizuoka
Japan	Research Site	Hirakata	Osaka
Japan	Research Site	Hitachi	Ibaragi
Japan	Research Site	Ihara	Okayama
Japan	Research Site	Itami	Hyogo
Japan	Research Site	Izunokuni	Shizuoka
Japan	Research Site	Kawagoe	Saitama
Japan	Research Site	Koto	Tokyo
Japan	Research Site	Koto	Hyogo
Japan	Research Site	Kyoto
Japan	Research Site	Maikinohara	Shizuoka
Japan	Research Site	Matsumoto	Nagano
Japan	Research Site	Mizumaki	Fukuoka
Japan	Research Site	Morioka	Iwate
Japan	Research Site	Musashimurayama	Tokyo
Japan	Research Site	Nagano
Japan	Research Site	Nagaokakyo	Kyoto
Japan	Research Site	Nishinomiya	Hyogo
Japan	Research Site	Oita
Japan	Research Site	Osaka
Japan	Research Site	Sagamihara	Kanagawa
Japan	Research Site	Saitama
Japan	Research Site	Sakai	Osaka
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sasebo	Nagasaki
Japan	Research Site	Seto	Aichi
Japan	Research Site	Shimotsuke	Tochigi
Japan	Research Site	Shizuoka
Japan	Research Site	Suita	Osaka
Japan	Research Site	Takatsuki	Osaka
Japan	Research Site	Yaizu	Shizuoka
Japan	Research Site	Yokohama	Kanagawa
Japan	Research Site	Yotukaido	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period	The absence of gastric and/or duodenal ulcer throughout the treatment period	each visit up to 24 weeks	No
Secondary	Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment	The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment	up to 4 weeks	No
Secondary	Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment	The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment	up to 12 weeks	No