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

This study is currently recruiting participants.
Verified November 2012 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01398410
First received: July 18, 2011
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

The primary objective of this study to examine the long-term safety of E3810 5 mg or 10 mg tablets administered once daily in patients who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in Trial 308.


Condition Intervention Phase
Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
 Drug: E3810
 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:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Long-term safety: The incidence rates of adverse events will be calculated for each treatment group [ Time Frame: 28-52 weeks ] [ Designated as safety issue: Yes ]
    For the E3810 continuing long-term administration groups (more than 52 weeks [including period of Trial 308]) or the E3810 new long-term administration groups (28-52 weeks), the incidence rates of adverse events will be calculated for each treatment group.


Secondary Outcome Measures:
  • Cumulative recurrent rates of gastric or duodenal ulcers [ Time Frame: 28-52 weeks and more than 52 weeks ] [ Designated as safety issue: No ]
    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. Cumulative recurrent rates will be estimated by the Kaplan-Meier method.


Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E3810 5 mg Drug: E3810
E3810 5 mg/day group: Orally administered E3810 5 mg tablets and 10 mg placebo tablets once daily after breakfast.
Experimental: E3810 10 mg Drug: E3810
E3810 10 mg/day group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast.

  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 Trial 308
  • Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this trial.

Exclusion Criteria

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

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

Contacts
Contact: Customer Joy Department. EJ _ML_CLNCL@hhc.eisai.co.jp

  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
Last Updated: November 6, 2012
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 Diseases
Duodenal Ulcer
Stomach Ulcer
Ulcer
Peptic Ulcer
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Aspirin
Rabeprazole
Proton Pump Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013