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

Eisai

Status and phase: Completed; Phase 3; Phase 2

Conditions: Refractory Reflux Esophagitis

Treatments: Drug: E3810

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770913

E3810-J081-304

Details and patient eligibility

About

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

Full 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.

Enrollment: 337 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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337 participants in 3 patient groups

1

Active Comparator group

Treatment:

Drug: E3810

Drug: E3810

Drug: E3810

2

Experimental group

Treatment:

Drug: E3810

Drug: E3810

Drug: E3810

3

Experimental group

Treatment:

Drug: E3810

Drug: E3810

Drug: E3810