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

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-

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.

Study Overview

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

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).

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Gifu, Japan
  • Kitakyushu, 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
    • Hirakat, 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: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rabeprazole 5 mg	Drug: Rabeprazole; Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily; Other Names: E3810, Pariet/Aciphex; Drug: Rabeprazole; Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily; Other Names: E3810, Pariet/Aciphex
Experimental: Rabeprazole 10 mg	Drug: Rabeprazole; Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily; Other Names: E3810, Pariet/Aciphex; Drug: Rabeprazole; Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily; Other Names: E3810, Pariet/Aciphex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment Emergent Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers	Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.	Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)

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: December 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

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; Stomach Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E3810-J081-309