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 |
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Recruitment Status
:
Completed
First Posted
: July 19, 2011
Results First Posted
: October 23, 2014
Last Update Posted
: November 26, 2014
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Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
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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 |
| 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.
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| 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.
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| 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.
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Primary Outcome Measures
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- 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
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- Cumulative Incidence of Bleeding Ulcers [ Time Frame: 24 weeks ]
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| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| 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
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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. ):
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Rabeprazole proton pump inhibitor Acetylsalicylic Acid |
Aspirin Gastric Ulcer Duodenal Ulcer |
Additional relevant MeSH terms:
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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 |