Status:
COMPLETED
A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Eisai Limited
Conditions:
Non-erosive Gastroesophageal Reflux Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/...
Eligibility Criteria
Inclusion
- The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked.
- \<For the observation period\>
- Patients who have "heartburn" 2 days a week or more during consecutive 3 weeks\* prior to pre-observation screening. \*If a day of screening and a day of starting observation (date of registration) are different, heartburn must continuously be present during the in-between period.
- Patients who meet both 1) and 2) below;
- 1\) The symptom is a burning sensation arising from the stomach or the lower chest.
- 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 this study and give written consent for study entry.
- \<For the treatment period\>
- Patients who have "heartburn" 2 days a week or more during 7 days until the treatment period (during the observation period).
- Patients with "heartburn diary" that is completely filled out during 7 days until the treatment period (during the observation period). If the observation period is 8 days or longer, those with a heartburn diary of which entries are fulfilled 80% or more during the observation period.
- Patients with 80% or better drug compliance for antacids during the observation period.
- Patients whose percentage of time showing pH\<4.0 (% time pH\<4.0) is not 0%\* during the 24-hour esophageal pH monitoring at the end of observation period (at the beginning of treatment period). \*If parameters calculated from analytical program show 0.0% after round-off, this patient cannot be entered into the treatment period.
Exclusion
- Patients who meet any of the following criteria will be excluded from the study.
- Patients who cannot keep adequate entries of a heartburn diary by themselves.
- Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
- Patients who have a complication or history of psychiatric or psychosomatic disease (e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic treatment).
- Patients who have undergone Helicobacter pylori eradication therapy, and less than 6 months\* have elapsed from the end of H. pylori eradication therapy to the beginning of the observation period. \*: The same day 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
- Patients with open gastric or duodenal ulcer.
- Patients with acute gastritis.
- Patients with a history of any surgical intervention that affect peptic secretion (e.g., upper gastrointestinal tract resection and/or vagotomy).
- Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
- Patients with scleroderma.
- Patients with a history or complication of angina pectoris.
- Patients who work at night (working for a night-shift).
- Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to pre-observation screening.
- Patients who need non steroidal anti-inflammatory drugs (NSAIDs) (except topical preparations), steroids (except topical preparations), and/or aspirin treatment every day.
- Patients receiving dialysis therapy.
- Patients with a serious complication such as cardiovascular disease (myocardial infarction, etc.), hematological disorder (e.g, aplastic anemia), renal disease (e.g., acute or chronic renal failure), hepatic disease (e.g., cirrhosis), or malignant tumor.
- Patients with known hypersensitivity to antacids or PPIs.
- Patients who are pregnant or those with childbearing potential, or those who wish to become pregnant or are lactating during the study period.
- Patients receiving another investigational drug or those who received another investigational drug within 6 months prior to pre-observation screening\* \*: Registration is allowed on the same day of 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
- Patients who are judged to be ineligible for the study entry by the investigator or subinvestigator.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00165672
Start Date
May 1 2005
End Date
October 1 2005
Last Update
October 5 2011
Active Locations (13)
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1
Nagoya, Aichi-ken, Japan, 467-0001
2
Fukuoka, Fukuoka, Japan, 810-0001
3
Fukuoka, Fukuoka, Japan, 811-0213
4
Yukuhashi, Fukuoka, Japan, 824-0026