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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01398410
First received: July 18, 2011
Last updated: November 19, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Drug: Rabeprazole
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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-

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cumulative Recurrent Rate of Gastric or Duodenal Ulcers [ Time Frame: Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase) ] [ Designated as safety issue: No ]
    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.


Enrollment: 405
Study Start Date: December 2011
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rabeprazole 5 mg Drug: Rabeprazole
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
Other Name: E3810, Pariet/Aciphex
Experimental: Rabeprazole 10 mg Drug: Rabeprazole
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
Other Name: E3810, Pariet/Aciphex

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398410

  Show 50 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Nobuyuki Sugisaki Japan/Asia Clinical Research Product Creation Unit
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01398410     History of Changes
Other Study ID Numbers: E3810-J081-309 
Study First Received: July 18, 2011
Results First Received: October 16, 2015
Last Updated: November 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Rabeprazole
proton pump inhibitor
Acetylsalicylic Acid
Aspirin
Gastric Ulcer
Duodenal Ulcer

Additional relevant MeSH terms:
Duodenal Ulcer
Stomach Ulcer
Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Peptic Ulcer
Stomach Diseases
Rabeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016