Conditions: Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Keywords: Rabeprazole proton pump inhibitor Acetylsalicylic Acid Aspirin Gastric Ulcer Duodenal Ulcer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 405
Healthy volunteers: no

Brief summary:
The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) \[Double-Blind Phase\] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

Detailed description:
The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Rabeprazole intervention 2: Rabeprazole
Intervention descriptions: intervention 1: Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily intervention 2: Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily

Protocol document: