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treatment in Trial 308 (at the start of this trial) and thus are withdrawn from the trial.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