Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

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-

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.

Study Overview

• Status: Completed
• Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
• Intervention / Treatment: Drug: E3810; Drug: E3810; Drug: Teprenone

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Gifu, Japan
  • Kochi, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Miyazaki, Japan
  • Nagano, Japan
  • Nagasaki, Japan
  • Oita, Japan
  • Osaka, Japan
  • Saga, Japan
  • Shizuoka, Japan
  • Aichi
    • Kasugai, Aichi, Japan
    • Nagoya, Aichi, Japan
  • Chiba
    • Ichikawa, Chiba, Japan
  • Fukuoka
    • Chikushino, Fukuoka, Japan
    • Kitakyushu, Fukuoka, Japan
    • Onga, Fukuoka, Japan
  • Gunma
    • Maebashi, Gunma, Japan
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
    • Sapporo, Hokkaido, Japan
    • Tomakomai, Hokkaido, Japan
  • Hyogo
    • Itami, Hyogo, Japan
    • Kobe, Hyogo, Japan
  • Ibaraki
    • Hitachi, Ibaraki, Japan
  • Kanagawa
    • Fujisawa, Kanagawa, Japan
    • Kawasaki, Kanagawa, Japan
    • Sagamihara, Kanagawa, Japan
    • Yokohama, Kanagawa, Japan
  • Kumamoto
    • Hitoyoshi, Kumamoto, Japan
  • Miyazaki
    • Ebino, Miyazaki, Japan
  • Nagano
    • Chikuma, Nagano, Japan
    • Matsumoto, Nagano, Japan
    • Suzaka, Nagano, Japan
  • Oita
    • Beppu, Oita, Japan
    • Yufu, Oita, Japan
  • Osaka
    • Daito, Osaka, Japan
    • Hirakata, Osaka, Japan
    • Matsubara, Osaka, Japan
    • Takatsuki, Osaka, Japan
    • Yao, Osaka, Japan
  • Saga
    • Karatsu, Saga, Japan
    • Ureshino, Saga, Japan
  • Shimane
    • Izumo, Shimane, Japan
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
  • Tochigi
    • Ohtawara, Tochigi, Japan
  • Tokyo
    • Mitaka, Tokyo, Japan
    • Setagaya, Tokyo, Japan
    • Shinjuku, Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E3810 5 mg	Drug: E3810; 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.; Drug: E3810; 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.
Experimental: E3810 10 mg	Drug: E3810; 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.; Drug: E3810; 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.
Active Comparator: Teprenone 150 mg	Drug: Teprenone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative Incidence of Bleeding Ulcers	24 weeks

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Nobuyuki Sugisaki, Japan/Asia Clinical Research Product Creation Unit

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Aspirin; Rabeprazole; proton pump inhibitor; Acetylsalicylic Acid; Gastric Ulcer; Duodenal Ulcer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E3810-J081-308