A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease

NCT00165672 | Completed Phase 3 Results

• 1 other identifier: E3810-J081-462
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 13

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/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).

Conditions

Non-erosive Gastroesophageal Reflux Disease

Keywords

24-hour esophageal pH monitoring; non-erosive gastroesophageal reflux disease; NERD; proton pump inhibitor; rabeprazole

Outcome Measures

Primary Outcomes (1)

• 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).

  Mean and standard deviation of percent time pH\<4.0 on 24 hour esophageal pH monitoring.

  Baseline and 4 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: RABEPRAZOLE SODIUM

2

EXPERIMENTAL

Drug: RABEPRAZOLE SODIUM

Interventions

RABEPRAZOLE SODIUM DRUG

rabeprazole sodium 5 mg: once daily orally for 4 weeks

1

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 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;
• \) 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.
• \. Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
• \. Patients who are 20 years old or older at the time of obtaining consent.
• \. 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.

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 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.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Limited: collaborator

Study Sites (13)

Unknown Facility

Nagoya, Aichi-ken, 467-0001, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-0001, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 811-0213, Japan

Location

Unknown Facility

Yukuhashi, Fukuoka, 824-0026, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 734-0037, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0012, Japan

Location

Unknown Facility

Osaka, Osaka, 545-0051, Japan

Location

Unknown Facility

Saga, Saga-ken, 849-0937, Japan

Location

Unknown Facility

Ōtsu, Shiga, 520-2121, Japan

Location

Unknown Facility

Izumo, Shimane, 693-0021, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-0022, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 162-0052, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-0046, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: October 5, 2011
• Results First Posted: October 5, 2011

Record last verified: 2010-08

Locations

JP (13)