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

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin

Intervention: E3810 (Drug); E3810 (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Nobuyuki Sugisaki, Study Director, Affiliation: Japan/Asia Clinical Research Product Creation Unit

Summary

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.

Clinical Details

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-

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Long-term safety: The incidence rates of adverse events will be calculated for each treatment group

Secondary outcome: Cumulative recurrent rates of gastric or duodenal ulcers

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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treatment in Trial 308 (at the start of this trial) and thus are withdrawn from the trial.

Locations and Contacts

Fukuoka, Japan

Gifu, Japan

Kitakyushu, Japan

Kochi, Japan

Kumamoto, Japan

Kyoto, Japan

Miyazaki, Japan

Nagano, Japan

Nagasaki, Japan

Oita, Japan

Osaka, Japan

Saga, Japan

Shizuoka, Japan

Kasugai, Aichi, Japan

Nagoya, Aichi, Japan

Ichikawa, Chiba, Japan

Chikushino, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Onga, Fukuoka, Japan

Maebashi, Gunma, Japan

Asahikawa, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Tomakomai, Hokkaido, Japan

Itami, Hyogo, Japan

Kobe, Hyogo, Japan

Hitachi, Ibaraki, Japan

Fujisawa, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Hitoyoshi, Kumamoto, Japan

Ebino, Miyazaki, Japan

Chikuma, Nagano, Japan

Matsumoto, Nagano, Japan

Suzaka, Nagano, Japan

Beppu, Oita, Japan

Yufu, Oita, Japan

Daito, Osaka, Japan

Hirakat, Osaka, Japan

Matsubara, Osaka, Japan

Takatsuki, Osaka, Japan

Yao, Osaka, Japan

Karatsu, Saga, Japan

Ureshino, Saga, Japan

Izumo, Shimane, Japan

Hamamatsu, Shizuoka, Japan

Ohtawara, Tochigi, Japan

Mitaka, Tokyo, Japan

Setagaya, Tokyo, Japan

Shinjuku, Tokyo, Japan

Additional Information

Starting date: December 2011
Last updated: July 10, 2014

Page last updated: August 20, 2015

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