Clinical trial NCT00542789: Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Duodenal Ulcer
Rheumatoid Arthritis
Osteoarthritis
Lumbago
Keywords: gastrointestinal
GI
NSAID
Japan
Japanese
Gastric ulcer
duodenal ulcer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 343
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
timeFrame: each visit up to 24 weeks
Secondary outcomes:
measure: Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
timeFrame: up to 4 weeks
measure: Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Chiryu
country: Japan
facility: Research Site
state: Aichi
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Yotukaido
country: Japan
facility: Research Site
state: Chiba
city: Mizumaki
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: HYOGOi
city: Itami
country: Japan
facility: Research Site
state: Hyogo
city: Koto
country: Japan
facility: Research Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Research Site
state: Hyogo
city: Hitachi
country: Japan
facility: Research Site
state: Ibaragi
city: Morioka
country: Japan
facility: Research Site
state: Iwate
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Nagaokakyo
country: Japan
facility: Research Site
state: Kyoto
city: Chiisagata
country: Japan
facility: Research Site
state: Nagano
city: Matsumoto
country: Japan
facility: Research Site
state: Nagano
city: Sasebo
country: Japan
facility: Research Site
state: Nagasaki
city: Beppu
country: Japan
facility: Research Site
state: Oita
city: Ihara
country: Japan
facility: Research Site
state: Okayama
city: Hirakata
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Takatsuki
country: Japan
facility: Research Site
state: Osaka
city: Kawagoe
country: Japan
facility: Research Site
state: Saitama
city: Fukuroi
country: Japan
facility: Research Site
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Research Site
state: Shizuoka
city: Izunokuni
country: Japan
facility: Research Site
state: Shizuoka
city: Maikinohara
country: Japan
facility: Research Site
state: Shizuoka
city: Yaizu
country: Japan
facility: Research Site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Research Site
state: Tochigi
city: Chiyoda
country: Japan
facility: Research Site
state: Tokyo
city: Koto
country: Japan
facility: Research Site
state: Tokyo
city: Musashimurayama
country: Japan
facility: Research Site
state: Tokyo
city: Kyoto
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca Japan
name: Naotsugu Oyama
role: STUDY_DIRECTOR
References:
citation: Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16.