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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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ClinicalTrials.gov Identifier: NCT01397448
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : October 23, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Gastric or Duodenal Ulcers Caused by Low-dose Aspirin Drug: E3810 Drug: Teprenone Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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.

Experimental: E3810 10 mg 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.




Primary Outcome Measures :
  1. Cumulative Recurrent Rates of Gastric or Duodenal Ulcers [ Time Frame: 24 weeks ]
    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 :
  1. Cumulative Incidence of Bleeding Ulcers [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397448


  Show 49 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Nobuyuki Sugisaki Japan/Asia Clinical Research Product Creation Unit

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01397448     History of Changes
Other Study ID Numbers: E3810-J081-308
First Posted: July 19, 2011    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: November 26, 2014
Last Verified: October 2014

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Rabeprazole
proton pump inhibitor
Acetylsalicylic Acid
Aspirin
Gastric Ulcer
Duodenal Ulcer

Additional relevant MeSH terms:
Aspirin
Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Rabeprazole
Geranylgeranylacetone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors