|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-Erosive Gastroesophageal Reflux Disease | ||||
| Official Title † | A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-Erosive Gastroesophageal Reflux Disease | ||||
| Brief Summary | To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study. Primary endpoint is set as complete relief rate of heartburn at the end of evaluation. |
||||
| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Effects of E3810 on heartburn will be evaluated using patients' heartburn diary. The severity of heartburn will be graded as "mild," "moderate," or "severe." | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Non-Erosive Gastroesophageal Reflux Disease | ||||
| Intervention † | Drug: RABEPRAZOLE SODIUM | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 300 | ||||
| Start Date † | September 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria: The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked. <For the observation period>
2) The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen. (3) Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis. (4) Patients who are 20 years old or older at the time of obtaining consent. (5) Patients who are informed of the objective and details of the study and give written consent for study entry. <For the treatment period>
Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study.
|
||||
| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Japan | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00165646 | ||||
| Organization ID | E3810-J081-461 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Eisai Inc. | ||||
| Collaborators †† | Eisai Limited | ||||
| Investigators † |
|
||||
| Information Provided By | Eisai Medical Research Inc. | ||||
| Verification Date | July 2007 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | July 31, 2007 | ||||