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

Condition(s) targeted: Refractory Reflux Esophagitis

Intervention: E3810 (Drug); E3810 (Drug); E3810 (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Tomoki Kubota, Study Director, Affiliation: Development Clinical Research Dept., Clinical Research Center

Overall contact:
Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

The purpose of this study is to evaluate the efficacy and safety of E3810 (Aciphex) tablets in patients with Proton Pump Inhibitor-resistant 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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Upper GI endoscopy (EGD)

Secondary outcome: Adverse events, lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin, etc.)

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.

2. Proton-Pump Inhibitor (PPI) standard dose-resistant reflux esophagitis.

3. Patients who are 20 years and older when informed consent is obtained.

Exclusion Criteria:

1. Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.

2. Patients with malignancy.

3. Patients who are taking another trial drug or the interval between the end of its treatment and screening is less than 12 weeks.

Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

Akita, Japan; Recruiting

Hiroshima, Japan; Recruiting

Kouchi, Japan; Recruiting

Kumamoto, Japan; Recruiting

Kyoto, Japan; Recruiting

Nagasaki, Japan; Recruiting

Oita, Japan; Recruiting

Okayama, Japan; Recruiting

Osaka, Japan; Recruiting

Saga, Japan; Recruiting

Shizuoka, Japan; Recruiting

Yamagata, Japan; Recruiting

Nagoya, Aichi, Japan; Recruiting

Nagakute, Aichi, Japan; Recruiting

Omuta, Fukuoka, Japan; Recruiting

Tagawa, Fukuoka, Japan; Recruiting

Chikushino, Fukuoka, Japan; Recruiting

Koriyama, Fukushima, Japan; Recruiting

Maebashi, Gunma, Japan; Recruiting

Sapporo, Hokkaido, Japan; Recruiting

Asahikawa, Hokkaido, Japan; Recruiting

Nishinomiya, Hyogo, Japan; Recruiting

Hitachi, Ibaragi, Japan; Recruiting

Takamatsu, Kagawa, Japan; Recruiting

Kirishima, Kagoshima, Japan; Recruiting

Yokohama, Kanagawa, Japan; Recruiting

Ishinomaki, Miyagi, Japan; Recruiting

Hirakata, Osaka, Japan; Recruiting

Karatsu, Saga, Japan; Recruiting

Kusatsu, Shiga, Japan; Recruiting

Matsue, Shimane, Japan; Recruiting

Izumo, Shimane, Japan; Recruiting

Shimada, Shizuoka, Japan; Recruiting

Fujieda, Shizuoka, Japan; Recruiting

Hamamatsu, Shizuoka, Japan; Recruiting

Itabashi, Tokyo, Japan; Recruiting

Shinjuku, Tokyo, Japan; Recruiting

Bunkyo, Tokyo, Japan; Recruiting

Shinagawa, Tokyo, Japan; Recruiting

Shimonoseki, Yamaguchi, Japan; Recruiting

Hofu, Yamaguchi, Japan; Recruiting

Starting date: October 2008
Last updated: August 26, 2009