Back to resultsPrevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Primary Purpose
Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E3810
E3810
Teprenone
Sponsored by
About this trial
This is an interventional prevention trial for Gastric or Duodenal Ulcers Caused by Low-dose Aspirin focused on measuring Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
E3810 5 mg
E3810 10 mg
Teprenone 150 mg
Arm Description
Outcomes
Primary Outcome Measures
Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
Secondary Outcome Measures
Cumulative Incidence of Bleeding Ulcers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01397448
Brief Title
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Keywords
Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
472 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E3810 5 mg
Arm Type
Experimental
Arm Title
E3810 10 mg
Arm Type
Experimental
Arm Title
Teprenone 150 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
E3810
Intervention Description
E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
Intervention Type
Drug
Intervention Name(s)
E3810
Intervention Description
E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
Intervention Type
Drug
Intervention Name(s)
Teprenone
Intervention Description
Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.
Primary Outcome Measure Information:
Title
Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Description
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Cumulative Incidence of Bleeding Ulcers
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sugisaki
Organizational Affiliation
Japan/Asia Clinical Research Product Creation Unit
Official's Role
Study Director
Facility Information:
City
Kasugai
State/Province
Aichi
Country
Japan
City
Nagoya
State/Province
Aichi
Country
Japan
City
Ichikawa
State/Province
Chiba
Country
Japan
City
Chikushino
State/Province
Fukuoka
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Onga
State/Province
Fukuoka
Country
Japan
City
Maebashi
State/Province
Gunma
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Tomakomai
State/Province
Hokkaido
Country
Japan
City
Itami
State/Province
Hyogo
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Hitachi
State/Province
Ibaraki
Country
Japan
City
Fujisawa
State/Province
Kanagawa
Country
Japan
City
Kawasaki
State/Province
Kanagawa
Country
Japan
City
Sagamihara
State/Province
Kanagawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Hitoyoshi
State/Province
Kumamoto
Country
Japan
City
Ebino
State/Province
Miyazaki
Country
Japan
City
Chikuma
State/Province
Nagano
Country
Japan
City
Matsumoto
State/Province
Nagano
Country
Japan
City
Suzaka
State/Province
Nagano
Country
Japan
City
Beppu
State/Province
Oita
Country
Japan
City
Yufu
State/Province
Oita
Country
Japan
City
Daito
State/Province
Osaka
Country
Japan
City
Hirakata
State/Province
Osaka
Country
Japan
City
Matsubara
State/Province
Osaka
Country
Japan
City
Takatsuki
State/Province
Osaka
Country
Japan
City
Yao
State/Province
Osaka
Country
Japan
City
Karatsu
State/Province
Saga
Country
Japan
City
Ureshino
State/Province
Saga
Country
Japan
City
Izumo
State/Province
Shimane
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
City
Ohtawara
State/Province
Tochigi
Country
Japan
City
Mitaka
State/Province
Tokyo
Country
Japan
City
Setagaya
State/Province
Tokyo
Country
Japan
City
Shinjuku
State/Province
Tokyo
Country
Japan
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
12. IPD Sharing Statement
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Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
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