--- title: "A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)" nct_id: NCT01089543 overall_status: COMPLETED phase: PHASE2 sponsor: Eisai Co., Ltd. study_type: INTERVENTIONAL primary_condition: Functional Dyspepsia countries: Japan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01089543.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01089543" ct_last_update_post_date: 2013-12-24 last_seen_at: "2026-05-12T06:46:51.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204) **Official Title:** A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia **NCT ID:** [NCT01089543](https://clinicaltrials.gov/study/NCT01089543) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 338 - **Lead Sponsor:** Eisai Co., Ltd. - **Conditions:** Functional Dyspepsia - **Start Date:** 2010-04 - **Completion Date:** 2011-08 - **CT.gov Last Update:** 2013-12-24 ## Brief Summary The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia. ## Eligibility - **Minimum age:** 20 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion criteria: -Participants diagnosed as Functional Dyspepsia according to Rome III criteria. Exclusion criteria: * Participants with neuropsychiatric disorder. * Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation. ``` ## Arms - **Rabeprazole 10 mg** (EXPERIMENTAL) - **Rabeprazole 20 mg** (EXPERIMENTAL) - **Rabeprazole 40 mg** (EXPERIMENTAL) - **Placebo** (PLACEBO_COMPARATOR) ## Interventions - **Rabeprazole** (DRUG) — Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. - **Rabeprazole** (DRUG) — Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. - **Rabeprazole** (DRUG) — Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. - **Placebo** (DRUG) — Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks. ## Primary Outcomes - **Rate of Complete Dyspepsia Symptom Relief** _(time frame: Up to 8 Weeks (including 7 days prior))_ — The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. ## Secondary Outcomes - **Rate of Satisfactory Symptom Relief** _(time frame: Up to 8 Weeks (including 7 days prior))_ ## Locations (46) - Nagoya, Aichi-ken, Japan - Akita, Akita, Japan - Chikushino-shi, Fukuoka, Japan - Fukuoka, Fukuoka, Japan - Kitakyushu, Fukuoka, Japan - Gifu, Gifu, Japan - Maebashi, Gunma, Japan - Hiroshima, Hiroshima, Japan - Sapporo, Hokkaido, Japan - Kobe, Hyōgo, Japan - Nishinomiya, Hyōgo, Japan - Tsuchiura, Ibaraki, Japan - Takamatsu, Kagawa-ken, Japan - Kagoshima, Kagoshima-ken, Japan - Yokohama, Kanagawa, Japan - Kochi, Kochi, Japan - Kumamoto, Kumamoto, Japan - Kyoto, Kyoto, Japan - Sendai, Miyagi, Japan - Miyazaki, Miyazaki, Japan - Ōita, Oita Prefecture, Japan - Yufu, Oita Prefecture, Japan - Nakagami, Okinawa, Japan - Hirakata, Osaka, Japan - Moriguchi, Osaka, Japan - Osaka, Osaka, Japan - Suita, Osaka, Japan - Takatsuki, Osaka, Japan - Karatsu, Saga-ken, Japan - Saga, Saga-ken, Japan - Saitama, Saitama, Japan - Kusatsu, Shiga, Japan - Izumo, Shimane, Japan - Fujieda, Shizuoka, Japan - Hamamatsu, Shizuoka, Japan - Shizuoka, Shizuoka, Japan - Ōtawara, Tochigi, Japan - Shimotsuga, Tochigi, Japan - Bunkyo, Tokyo, Japan - Mitaka, Tokyo, Japan - Nakano City, Tokyo, Japan - Ōta-ku, Tokyo, Japan - Setagaya City, Tokyo, Japan - Shibuya City, Tokyo, Japan - Shinagawa, Tokyo, Japan - Yamagata, Yamagata, Japan ## Recent Field Changes (last 30 days) - `locations.|maebashi|gunma|japan` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|nagoya|aichi-ken|japan` — added _(2026-05-12)_ - `locations.|akita|akita|japan` — added _(2026-05-12)_ - `locations.|chikushino-shi|fukuoka|japan` — added _(2026-05-12)_ - `locations.|fukuoka|fukuoka|japan` — added _(2026-05-12)_ - `locations.|kitakyushu|fukuoka|japan` — added _(2026-05-12)_ - `locations.|gifu|gifu|japan` — added _(2026-05-12)_ - `locations.|hiroshima|hiroshima|japan` — added _(2026-05-12)_ - `locations.|sapporo|hokkaido|japan` — added _(2026-05-12)_ - `locations.|kobe|hyōgo|japan` — added _(2026-05-12)_ - `locations.|nishinomiya|hyōgo|japan` — added _(2026-05-12)_ - `locations.|tsuchiura|ibaraki|japan` — added _(2026-05-12)_ - `locations.|takamatsu|kagawa-ken|japan` — added _(2026-05-12)_ - `locations.|kagoshima|kagoshima-ken|japan` — added _(2026-05-12)_ - `locations.|yokohama|kanagawa|japan` — added _(2026-05-12)_ - `locations.|kochi|kochi|japan` — added _(2026-05-12)_ - `locations.|kumamoto|kumamoto|japan` — added _(2026-05-12)_ - `locations.|kyoto|kyoto|japan` — added _(2026-05-12)_ - `locations.|sendai|miyagi|japan` — added _(2026-05-12)_ - `locations.|miyazaki|miyazaki|japan` — added _(2026-05-12)_ - `locations.|ōita|oita prefecture|japan` — added _(2026-05-12)_ - `locations.|yufu|oita prefecture|japan` — added _(2026-05-12)_ - `locations.|nakagami|okinawa|japan` — added _(2026-05-12)_ - `locations.|hirakata|osaka|japan` — added _(2026-05-12)_ - `locations.|moriguchi|osaka|japan` — added _(2026-05-12)_ - `locations.|osaka|osaka|japan` — added _(2026-05-12)_ - `locations.|suita|osaka|japan` — added _(2026-05-12)_ - `locations.|takatsuki|osaka|japan` — added _(2026-05-12)_ - `locations.|karatsu|saga-ken|japan` — added _(2026-05-12)_ - `locations.|saga|saga-ken|japan` — added _(2026-05-12)_ - `locations.|saitama|saitama|japan` — added _(2026-05-12)_ - `locations.|kusatsu|shiga|japan` — added _(2026-05-12)_ - `locations.|izumo|shimane|japan` — added _(2026-05-12)_ - `locations.|fujieda|shizuoka|japan` — added _(2026-05-12)_ - `locations.|hamamatsu|shizuoka|japan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01089543.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01089543* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*