Clinical trial NCT00770913: Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
Official title: Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Refractory Reflux Esophagitis
Keywords: reflux esophagitis
rabeprazole
GERD
Japan
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 337
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

Detailed description: This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.

Eligibility criteria: Inclusion Criteria:

* Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.
* Proton Pump Inhibitor standard dose-resistant reflux esophagitis.
* Patients who are 20 years and older when informed consent is obtained.

Exclusion Criteria:

* Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.
* Patients with malignancy.
* Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.

Primary outcomes:
measure: Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nagakute
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Abiko
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Yachiyo
country: Japan
state: Chiba
city: Chikushino
country: Japan
state: Fukuoka
city: Omuta
country: Japan
state: Fukuoka
city: Tagawa
country: Japan
state: Fukuoka
city: Koriyama
country: Japan
state: Fukushima
city: Hashima
country: Japan
state: Gifu
city: Maebashi
country: Japan
state: Gunma
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Itami
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Hitachi
country: Japan
state: Ibaraki
city: Takamatsu
country: Japan
state: Kagawa
city: Kirishima
country: Japan
state: Kagoshima
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Ishinomaki
country: Japan
state: Miyagi
city: Yamatokoriyama
country: Japan
state: Nara
city: Beppu
country: Japan
state: Oita
city: Hirakata
country: Japan
state: Osaka
city: Karatsu
country: Japan
state: Saga
city: Kusatsu
country: Japan
state: Shiga
city: Izumo
country: Japan
state: Shimane
city: Matsue
country: Japan
state: Shimane
city: Fujieda
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Shimada
country: Japan
state: Shizuoka
city: Ohtawara
country: Japan
state: Tochigi
city: Bunkyo
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Hofu
country: Japan
state: Yamaguchi
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Akita
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kouchi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Nagasaki
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Shizuoka
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: New Product Development Dept., Clinical Research Center
name: Tomoki Kubota
role: STUDY_DIRECTOR
References: