|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | July 31, 2007 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Effects of E3810 on heartburn will be evaluated using patients' heartburn diary. The severity of heartburn will be graded as "mild," "moderate," or "severe." | ||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00165646 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-Erosive Gastroesophageal Reflux Disease | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Non-Erosive Gastroesophageal Reflux Disease | ||||
| Intervention ICMJE | Drug: RABEPRAZOLE SODIUM | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00165646 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | E3810-J081-461 | ||||
| Study Sponsor ICMJE | Eisai Inc. | ||||
| Collaborators ICMJE | Eisai Limited | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Eisai Inc. | ||||
| Verification Date | July 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||