Trials / Completed
CompletedNCT01398410
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
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-
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 405 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rabeprazole | Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily |
| DRUG | Rabeprazole | Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2013-12-01
- Completion
- 2014-02-01
- First posted
- 2011-07-20
- Last updated
- 2015-12-21
- Results posted
- 2015-11-16
Locations
50 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01398410. Inclusion in this directory is not an endorsement.