Clinical trial NCT01398410: Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Official title: Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Open-label Trial-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastric Ulcers 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: 2011-07-20
Enrollment: 405
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 examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) \[Double-Blind Phase\] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

Detailed description: The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).

Eligibility criteria: Inclusion Criteria

* Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
* Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.

Exclusion Criteria

-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.

Primary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)
Secondary outcomes:
measure: Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
timeFrame: Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)
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: Hirakat
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: Kitakyushu
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: