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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00770913
First received: October 9, 2008
Last updated: April 16, 2012
Last verified: June 2010
History of Changes

October 9, 2008
April 16, 2012
October 2008
November 2009   (final data collection date for primary outcome measure)
Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Grade N indicates a normal appearance of lower esophageal mucosa
Upper GI endoscopy (EGD) [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00770913 on ClinicalTrials.gov Archive Site
Not Provided
Adverse events, lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin, etc.) [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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

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

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Refractory Reflux Esophagitis
  • Drug: E3810
    20 mg taken orally, once a day for 8 weeks.
    Other Name: Aciphex
  • Drug: E3810
    10 mg, taken orally, twice a day for 8 weeks.
    Other Name: Aciphex
  • Drug: E3810
    20 mg taken orally, twice a day for 8 weeks.
    Other Name: Aciphex
  • Active Comparator: 1
    Intervention: Drug: E3810
  • Experimental: 2
    Intervention: Drug: E3810
  • Experimental: 3
    Intervention: Drug: E3810
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
337
March 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00770913
E3810-J081-304
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Tomoki Kubota New Product Development Dept., Clinical Research Center
Eisai Inc.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP