A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-erosive Gastroesophageal Reflux Disease
Intervention: RABEPRAZOLE SODIUM (Drug); RABEPRAZOLE SODIUM (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s): Nobuyuki Sugisaki, Study Director, Affiliation: Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
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/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).
Clinical Details
Official title: A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
The patients to be included will be outpatients who meet all of the following criteria. No
specific gender is asked.
1. 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.
2. 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.
1. Patients who have "heartburn" 2 days a week or more during 7 days until the treatment
period (during the observation period).
2. 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.
3. Patients with 80% or better drug compliance for antacids during the observation
period.
4. 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 Criteria:
Patients who meet any of the following criteria will be excluded from the study.
1. Patients who cannot keep adequate entries of a heartburn diary by themselves.
2. Patients who strongly complain "feeling of heavy stomach" and/or "abdominal
bloating."
3. 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).
4. 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.
5. Patients with open gastric or duodenal ulcer.
6. Patients with acute gastritis.
7. Patients with a history of any surgical intervention that affect peptic secretion
(e. g., upper gastrointestinal tract resection and/or vagotomy).
8. Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
9. Patients with scleroderma.
10. Patients with a history or complication of angina pectoris.
11. Patients who work at night (working for a night-shift).
12. Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to
pre-observation screening.
13. Patients who need non steroidal anti-inflammatory drugs (NSAIDs) (except topical
preparations), steroids (except topical preparations), and/or aspirin treatment every
day.
14. Patients receiving dialysis therapy.
15. 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.
16. Patients with known hypersensitivity to antacids or PPIs.
17. Patients who are pregnant or those with childbearing potential, or those who wish to
become pregnant or are lactating during the study period.
18. 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.
19. Patients who are judged to be ineligible for the study entry by the investigator or
subinvestigator.
Locations and Contacts
Nagoya, Aichi-Prefecture 467-0001, Japan
Fukuoka, Fukuoka-Prefecture 810-0001, Japan
Fukuoka, Fukuoka-Prefecture 811-0213, Japan
Yukuhashi, Fukuoka-Prefecture 824-0026, Japan
Hiroshima, Hiroshima-Prefecture 734-0037, Japan
Osaka, Osaka-Prefecture 530-0012, Japan
Osaka, Osaka-Prefecture 545-0051, Japan
Saga, Saga-Prefecture 849-0937, Japan
Otsu, Shiga-Prefecture 520-2121, Japan
Izumo, Shimane-Prefecture 693-0021, Japan
Bunkyo-ku, Tokyo 113-0022, Japan
Shinjuku-ku, Tokyo 162-0052, Japan
Ube, Yamaguchi-Prefecture 755-0046, Japan
Additional Information
Starting date: May 2005
Last updated: September 6, 2011
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