Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

NCT01398410 | Completed Phase 2 Results

• 1 other identifier: E3810-J081-309
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 50

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.

Conditions

Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin

Keywords

Rabeprazole; proton pump inhibitor; Acetylsalicylic Acid; Aspirin; Gastric Ulcer; Duodenal Ulcer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (2)

Rabeprazole 5 mg

EXPERIMENTAL

Drug: Rabeprazole

Rabeprazole 10 mg

EXPERIMENTAL

Drug: Rabeprazole

Interventions

Rabeprazole DRUG

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

Also known as: E3810, Pariet/Aciphex

Rabeprazole 5 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (50)

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Kasugai, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Ichikawa, Chiba, Japan

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Chikushino-shi, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Koga, Fukuoka, Japan

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Gifu, Gifu, Japan

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Maebashi, Gunma, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai, Hokkaido, Japan

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Itami, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Hitachi, Ibaraki, Japan

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Fujisawa, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kitakyushu, Kitakyushu, Japan

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Kochi, Kochi, Japan

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Hitoyoshi, Kumamoto, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Ebino, Miyazaki, Japan

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Miyazaki, Miyazaki, Japan

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Chikuma, Nagano, Japan

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Matsumoto, Nagano, Japan

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Nagano, Nagano, Japan

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Suzaka, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Beppu, Oita Prefecture, Japan

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Ōita, Oita Prefecture, Japan

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Yufu, Oita Prefecture, Japan

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Daitō, Osaka, Japan

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Hirakat, Osaka, Japan

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Matsubara, Osaka, Japan

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Osaka, Osaka, Japan

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Takatsuki, Osaka, Japan

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Yao, Osaka, Japan

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Karatsu, Saga-ken, Japan

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Saga, Saga-ken, Japan

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Ureshino, Saga-ken, Japan

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Izumo, Shimane, Japan

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Hamamatsu, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Ohtawara, Tochigi, Japan

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Mitaka, Tokyo, Japan

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Setagaya City, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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MeSH Terms

Conditions

Stomach Ulcer; Duodenal Ulcer

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Nobuyuki Sugisaki
• Organization: Eisai Co., Ltd.

+81-3-3817-3908

Study Officials

• Nobuyuki Sugisaki

  Japan/Asia Clinical Research Product Creation Unit

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 20, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: December 21, 2015
• Results First Posted: November 16, 2015

Record last verified: 2015-11

Locations

JP (50)