Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin Clinical Trial
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-
| Verified date | November 2015 |
| Source | Eisai Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 405 |
| Est. completion date | February 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria - Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308. - Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study. Exclusion Criteria -Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs. | For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase) | No |
| Secondary | Cumulative Recurrent Rate of Gastric or Duodenal Ulcers | Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers. | Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase) | No |