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Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

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ClinicalTrials.gov Identifier: NCT02423187
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.

Condition or disease Intervention/treatment
Gastric Ulcer Duodenal Ulcer Other: No Intervention

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Study Type : Observational
Actual Enrollment : 1568 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin
Actual Study Start Date : March 17, 2015
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Arm 1
Participants with combination therapy (rabeprazole and low-dose aspirin)
Other: No Intervention



Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Recurrence rate of peptic ulcer [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with long-term combination therapy with low-dose aspirin
Criteria

Inclusion criteria:

  1. Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole).
  2. Patients with a history of gastric/duodenal ulcers.
  3. Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.

Exclusion criteria:

  1. Patients with gastric/duodenal ulcers at the start of administration of rabeprazole.
  2. Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole.
  3. Patients with contraindication for rabeprazole.

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): NCT02423187


Locations
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Japan
Nagoya, Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Katsuya Sugizaki Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02423187     History of Changes
Other Study ID Numbers: PRT12T
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: July 2018
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Stomach ulcer
Duodenal ulcer
Rabeprazole
Recurrence
Additional relevant MeSH terms:
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Aspirin
Stomach Ulcer
Duodenal Ulcer
Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Rabeprazole
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