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A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165646
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : June 17, 2011
Last Update Posted : July 18, 2011
Sponsor:
Information provided by:
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Non-erosive Gastroesophageal Reflux Disease Drug: E3810 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: 1 Drug: E3810
E3810 5mg: once daily orally for 4 weeks

Experimental: 2 Drug: E3810
E3810 10mg: once daily orally for 4 weeks

Placebo Comparator: 3 Drug: Placebo
Placebo: once daily orally for 4 weeks




Primary Outcome Measures :
  1. Percentage of Participants With Complete Relief of Heartburn at Final Evaluation [ Time Frame: 4 weeks ]
    "Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165646


Locations
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Japan
Aichi-Gun, Aichi-Prefecture, Japan, 480-1103
Nagoya, Aichi-Prefecture, Japan, 466-0065
Nagoya, Aichi-Prefecture, Japan, 467-0001
Chikushino, Fukuoka-Prefecture, Japan, 818-0024
Chikushino, Fukuoka-Prefecture, Japan, 818-0067
Fukuoka, Fukuoka-Prefecture, Japan, 813-0003
Kita-kyushu, Fukuoka-Prefecture, Japan, 807-1262
Maebashi, Gunma-Prefecture, Japan, 371-0034
Hiroshima, Hiroshima-Prefecture, Japan, 730-0052
Hiroshima, Hiroshima-Prefecture, Japan, 734-0037
Sapporo, Hokkaido-Prefecture, Japan, 003-0021
Sapporo, Hokkaido-Prefecture, Japan, 060-0061
Sapporo, Hokkaido-Prefecture, Japan, 060-0814
Kochi, Kochi-Prefecture, Japan, 780-0901
Kyoto, Kyoto-Prefecture, Japan, 602-0000
Kyoto, Kyoto-Prefecture, Japan, 606-8397
Sandai, Miyagi-Prefecture, Japan, 980-0872
Sendai, Miyagi-Prefecture, Japan, 984-0075
Moriguchi, Osaka-Prefecture, Japan, 570-0021
Osaka, Osaka-Prefecture, Japan, 530-0012
Osaka, Osaka-Prefecture, Japan, 536-0002
Osaka, Osaka-Prefecture, Japan, 545-0051
Saga, Saga-Prefecture, Japan, 849-0937
Kawaguchi, Saitama-Prefecture, Japan, 332-0021
Izumo, Shimane-Prefecture, Japan, 693-0021
Matsue, Shimane-Prefecture, Japan, 690-0886
Hamamatsu, Shizuoka-Prefecture, Japan, 431-3125
Shinagawa-ku, Tokyo, Japan, 140-0011
Shinjuku-ku, Tokyo, Japan, 162-0052
Sanyoonoda, Yamaguchi-Prefecture, Japan, 756-0076
Sanyoonoda, Yamaguchi-Prefecture, Japan, 757-0002
Ube, Yamaguchi-Prefecture, Japan, 755-0004
Ube, Yamaguchi-Prefecture, Japan, 755-0046
Ube, Yamaguchi-Prefecture, Japan, 755-0067
Ube, Yamaguchi-Prefecture, Japan, 755-0077
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Nobuyuki Sugisaki Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
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Responsible Party: Nobuyuki Sugisaki, Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00165646    
Other Study ID Numbers: E3810-J081-461
First Posted: September 14, 2005    Key Record Dates
Results First Posted: June 17, 2011
Last Update Posted: July 18, 2011
Last Verified: August 2010
Keywords provided by Eisai Inc.:
non-erosive gastroesophageal reflux disease
NERD
proton pump inhibitor
rabeprazole
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action