Status:
COMPLETED
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
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Refractory Reflux Esophagitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
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 frequenc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00770913
Start Date
October 1 2008
End Date
March 1 2010
Last Update
April 18 2012
Active Locations (54)
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1
Nagakute, Aichi-ken, Japan
2
Nagoya, Aichi-ken, Japan
3
Akita, Akita, Japan
4
Abiko, Chiba, Japan