Clinical trial NCT00165646: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Gastroesophageal Reflux Disease
Keywords: non-erosive gastroesophageal reflux disease
NERD
proton pump inhibitor
rabeprazole
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 288
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.


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\>

1. Patients who have "heartburn" 2 days a week or more for consecutive weeks during 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 the study and give written consent for study entry.

\<For the treatment period\>

1. Patients who have "heartburn" on 2 days a week or more in 7 days immediately before the treatment period (during the observation period).
2. Patients with "heartburn diary" that is completely filled out for 7 days until the treatment period (during the observation period). If the observation period is 8 days or longer, those with 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.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. Patients who cannot keep adequate entries of 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 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 (e.g., myocardial infarction), 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.

Primary outcomes:
measure: Percentage of Participants With Complete Relief of Heartburn at Final Evaluation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi-Gun
country: Japan
state: Aichi-Prefecture
city: Nagoya
country: Japan
state: Aichi-Prefecture
city: Nagoya
country: Japan
state: Aichi-Prefecture
city: Chikushino
country: Japan
state: Fukuoka-Prefecture
city: Chikushino
country: Japan
state: Fukuoka-Prefecture
city: Fukuoka
country: Japan
state: Fukuoka-Prefecture
city: Kita-kyushu
country: Japan
state: Fukuoka-Prefecture
city: Maebashi
country: Japan
state: Gunma-Prefecture
city: Hiroshima
country: Japan
state: Hiroshima-Prefecture
city: Hiroshima
country: Japan
state: Hiroshima-Prefecture
city: Sapporo
country: Japan
state: Hokkaido-Prefecture
city: Sapporo
country: Japan
state: Hokkaido-Prefecture
city: Sapporo
country: Japan
state: Hokkaido-Prefecture
city: Kochi
country: Japan
state: Kochi-Prefecture
city: Kyoto
country: Japan
state: Kyoto-Prefecture
city: Kyoto
country: Japan
state: Kyoto-Prefecture
city: Sandai
country: Japan
state: Miyagi-Prefecture
city: Sendai
country: Japan
state: Miyagi-Prefecture
city: Moriguchi
country: Japan
state: Osaka-Prefecture
city: Osaka
country: Japan
state: Osaka-Prefecture
city: Osaka
country: Japan
state: Osaka-Prefecture
city: Osaka
country: Japan
state: Osaka-Prefecture
city: Saga
country: Japan
state: Saga-Prefecture
city: Kawaguchi
country: Japan
state: Saitama-Prefecture
city: Izumo
country: Japan
state: Shimane-Prefecture
city: Matsue
country: Japan
state: Shimane-Prefecture
city: Hamamatsu
country: Japan
state: Shizuoka-Prefecture
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Sanyoonoda
country: Japan
state: Yamaguchi-Prefecture
city: Sanyoonoda
country: Japan
state: Yamaguchi-Prefecture
city: Ube
country: Japan
state: Yamaguchi-Prefecture
city: Ube
country: Japan
state: Yamaguchi-Prefecture
city: Ube
country: Japan
state: Yamaguchi-Prefecture
city: Ube
country: Japan
state: Yamaguchi-Prefecture
Study officials:
affiliation: Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
name: Nobuyuki Sugisaki
role: STUDY_DIRECTOR
References: