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-

Sponsors

Lead Sponsor: Eisai Co., Ltd.

Source Eisai Inc.
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).

Overall Status Completed
Start Date December 2011
Completion Date February 2014
Primary Completion Date December 2013
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Treatment Emergent Adverse Events (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)
Secondary Outcome
Measure Time Frame
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)
Enrollment 405
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rabeprazole

Description: Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily

Arm Group Label: Rabeprazole 5 mg

Other Name: E3810, Pariet/Aciphex

Intervention Type: Drug

Intervention Name: Rabeprazole

Description: Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily

Arm Group Label: Rabeprazole 10 mg

Other Name: E3810, Pariet/Aciphex

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nobuyuki Sugisaki Study Director Japan/Asia Clinical Research Product Creation Unit
Location
Facility:
| 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
| 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
Location Countries

Japan

Verification Date

November 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rabeprazole 5 mg

Type: Experimental

Label: Rabeprazole 10 mg

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov