A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

517

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

June 30, 2016

Conditions
Gastroesophageal Reflux Disease
Interventions
DRUG

Rabeprazole

Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).

DRUG

Rabeprazole

Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).

DRUG

Rabeprazole

Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).

DRUG

Rabeprazole

Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).

Trial Locations (61)

Unknown

Nagoya

Inzai

Kamagaya

Matsuyama

Kitakyushu

Koga

Kōriyama

Annaka

Fukuyama

Asahikawa

Ishikari

Sapporo

Amagasaki

Kobe

Nishinomiya

Furukawa

Tsuchiura

Takamatsu

Ichikikushikino-shi

Kamakura

Kawasaki

Yokohama

Sendai

Suwa

Beppu

Fujiidera

Hirakata

Kishiwada

Takatsuki

Karatsu

Ureshino

Ageo

Hiki

Toda

Wako

Izumo

Fujieda

Hamamatsu

Ōtawara

Adachi City

Bunkyo

Chūō

Koto

Minato

Nerima City

Ōta-ku

Setagaya City

Shibuya City

Shinagawa

Toshima City

Akita

Fukuoka

Hiroshima

Kochi

Kyoto

Nagasaki

Osaka

Ōita

Saga

Saitama

Yamagata

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT02135107 - A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients | Biotech Hunter | Biotech Hunter