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

NCT00165646 | Completed Phase 3 Results

• 1 other identifier: E3810-J081-461
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 35

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.

Conditions

Non-erosive Gastroesophageal Reflux Disease

Keywords

non-erosive gastroesophageal reflux disease; NERD; proton pump inhibitor; rabeprazole

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Relief of Heartburn at Final Evaluation

  "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

  4 weeks

Study Arms (3)

1

EXPERIMENTAL

Drug: E3810

2

EXPERIMENTAL

Drug: E3810

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E3810 DRUG

E3810 5mg: once daily orally for 4 weeks

1

Placebo DRUG

Placebo: once daily orally for 4 weeks

3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• Patients who meet both 1) and 2) below; 1) The symptom is a burning sensation arising from the stomach or the lower chest.
• \) 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\>
• Patients who have "heartburn" on 2 days a week or more in 7 days immediately before the treatment period (during the observation period).
• 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.
• Patients with 80% or better drug compliance for antacids during the observation period.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study.
• Patients who cannot keep adequate entries of 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 NSAIDs (except topical preparations), steroids (except topical preparations), and/or aspirin treatment every day
• Patients receiving dialysis therapy

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (35)

Unknown Facility

Aichi-Gun, Aichi-ken, 480-1103, Japan

Location

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Nagoya, Aichi-ken, 466-0065, Japan

Location

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Nagoya, Aichi-ken, 467-0001, Japan

Location

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Chikushino-shi, Fukuoka, 818-0024, Japan

Location

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Chikushino-shi, Fukuoka, 818-0067, Japan

Location

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Fukuoka, Fukuoka, 813-0003, Japan

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Kitakyushu, Fukuoka, 807-1262, Japan

Location

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Maebashi, Gunma, 371-0034, Japan

Location

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Hiroshima, Hiroshima, 730-0052, Japan

Location

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Hiroshima, Hiroshima, 734-0037, Japan

Location

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Sapporo, Hokkaido-Prefecture, 003-0021, Japan

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Sapporo, Hokkaido-Prefecture, 060-0061, Japan

Location

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Sapporo, Hokkaido-Prefecture, 060-0814, Japan

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Kochi, Kochi, 780-0901, Japan

Location

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Kyoto, Kyoto, 602-0000, Japan

Location

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Kyoto, Kyoto, 606-8397, Japan

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Sandai, Miyagi, 980-0872, Japan

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Sendai, Miyagi, 984-0075, Japan

Location

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Moriguchi, Osaka, 570-0021, Japan

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Osaka, Osaka, 530-0012, Japan

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Osaka, Osaka, 536-0002, Japan

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Osaka, Osaka, 545-0051, Japan

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Saga, Saga-ken, 849-0937, Japan

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Kawaguchi, Saitama, 332-0021, Japan

Location

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Izumo, Shimane, 693-0021, Japan

Location

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Matsue, Shimane, 690-0886, Japan

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Hamamatsu, Shizuoka, 431-3125, Japan

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Shinagawa-ku, Tokyo, 140-0011, Japan

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Shinjuku-ku, Tokyo, 162-0052, Japan

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Sanyōonoda, Yamaguchi, 756-0076, Japan

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Sanyōonoda, Yamaguchi, 757-0002, Japan

Location

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Ube, Yamaguchi, 755-0004, Japan

Location

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Ube, Yamaguchi, 755-0046, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-0067, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-0077, Japan

Location

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Nobuyuki Sugisaki, Study Director
• Organization: Eisai Co.,Ltd. Eisai Product Creation Systems

n-sugisaki@hhc.eisai.co.jp

+81-3-3817-3908

Study Officials

• Nobuyuki Sugisaki

  Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: July 18, 2011
• Results First Posted: June 17, 2011

Record last verified: 2010-08

Locations

JP (35)