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OpenTrials
Completed

NCT Number: NCT02423187

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

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

Completed

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Key information

Conditions

Gastric Ulcer Digestive System Diseases Disease Attributes Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Recurrence Stomach Diseases Stomach Ulcer

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Patients with a history of gastric/duodenal ulcers.
  • Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.

Exclusion criteria

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Incidence of adverse drug reactions

    Time frame: 52 weeks

Secondary outcomes

  1. Recurrence rate of peptic ulcer

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2015
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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