Clinical trial NCT01397448: Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Official title: Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Double-blind Comparative Trial-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Keywords: Rabeprazole
proton pump inhibitor
Acetylsalicylic Acid
Aspirin
Gastric Ulcer
Duodenal Ulcer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 472
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 primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.


Eligibility criteria: Inclusion Criteria

* Require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day)
* Confirmed to have a history of gastric or duodenal ulcer

Exclusion Criteria

-Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus

Primary outcomes:
measure: Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
timeFrame: 24 weeks
Secondary outcomes:
measure: Cumulative Incidence of Bleeding Ulcers
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kasugai
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Ichikawa
country: Japan
state: Chiba
city: Chikushino
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Onga
country: Japan
state: Fukuoka
city: Maebashi
country: Japan
state: Gunma
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Tomakomai
country: Japan
state: Hokkaido
city: Itami
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Hitachi
country: Japan
state: Ibaraki
city: Fujisawa
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Hitoyoshi
country: Japan
state: Kumamoto
city: Ebino
country: Japan
state: Miyazaki
city: Chikuma
country: Japan
state: Nagano
city: Matsumoto
country: Japan
state: Nagano
city: Suzaka
country: Japan
state: Nagano
city: Beppu
country: Japan
state: Oita
city: Yufu
country: Japan
state: Oita
city: Daito
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Matsubara
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Yao
country: Japan
state: Osaka
city: Karatsu
country: Japan
state: Saga
city: Ureshino
country: Japan
state: Saga
city: Izumo
country: Japan
state: Shimane
city: Hamamatsu
country: Japan
state: Shizuoka
city: Ohtawara
country: Japan
state: Tochigi
city: Mitaka
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Shizuoka
country: Japan
Study officials:
affiliation: Japan/Asia Clinical Research Product Creation Unit
name: Nobuyuki Sugisaki
role: STUDY_DIRECTOR
References: