Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
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.
Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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-|
- Long-term safety: The incidence rates of adverse events will be calculated for each treatment group [ Time Frame: 28-52 weeks ] [ Designated as safety issue: Yes ]For the E3810 continuing long-term administration groups (more than 52 weeks [including period of Trial 308]) or the E3810 new long-term administration groups (28-52 weeks), the incidence rates of adverse events will be calculated for each treatment group.
- Cumulative recurrent rates of gastric or duodenal ulcers [ Time Frame: 28-52 weeks and more than 52 weeks ] [ Designated as safety issue: No ]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. Cumulative recurrent rates will be estimated by the Kaplan-Meier method.
|Study Start Date:||December 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: E3810 5 mg||
E3810 5 mg/day group: Orally administered E3810 5 mg tablets and 10 mg placebo tablets once daily after breakfast.
|Experimental: E3810 10 mg||
E3810 10 mg/day group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398410
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|Study Director:||Nobuyuki Sugisaki||Japan/Asia Clinical Research Product Creation Unit|