NCT00125736

Brief Summary

The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2007

Completed
Last Updated

October 29, 2018

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

July 29, 2005

Last Update Submit

October 26, 2018

Conditions

Stomach Ulcer

Outcome Measures

Primary Outcomes (1)

  • Ratio of S2-stage transition at 8 weeks after the study administration.

    8 weeks

Study Arms (2)

E0671 combination group

EXPERIMENTAL
Drug: E0671Drug: rabeprazole sodium

placebo combination group

PLACEBO COMPARATOR
Drug: rabeprazole sodiumDrug: E0671 placebo

Interventions

E0671DRUG

One 50 mg capsule is orally administered three times daily (150 mg/day)

E0671 combination group
rabeprazole sodiumDRUG

One 10mg tablet is administered orally each day

E0671 combination groupplacebo combination group
E0671 placeboDRUG

One 50 mg capsule is orally administered three times daily (150 mg/day)

placebo combination group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with gastric ulcer (A1-and A2-stage)
  • Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked.
  • Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification).
  • Patients who are not younger than 20 years of age at the time of obtaining informed consent.
  • Patients who meet any of the following conditions:
  • H. pylori-negative
  • H. pylori-positive and not requiring eradication therapy
  • H. pylori-positive and unsuccessful eradication
  • Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.

You may not qualify if:

  • Patients with a complication of duodenal ulcer (excluding cicatrix).
  • Patients with reflux esophagitis
  • Patients with acute gastric mucosal lesions (AGML).
  • Patients with NSAID-induced ulcer.
  • Patients with linear ulcer.
  • Patients with ulcer injured by endoscopy.
  • Patients who underwent gastrectomy or vagal nerve resection.
  • Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc.
  • Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration.
  • Patients with serious cardiovascular diseases (e.g., angina pectoris, heart failure, acute myocardial ischemia, severe tachyarrhythmia), serious hematological disorders (e.g., aplastic anemia), serious renal disorders (e.g., acute, chronic renal failure), serious hepatic disorders (e.g., cirrhosis, severe hepatitis), serious pancreatic disorders (e.g., severe pancreatitis), serious psychoneuroses (e.g., schizophrenia, alcoholic dependency, drug dependency, severe depression), or cancer.
  • Patients with a current or a history of drug allergy to teprenone preparation(s).
  • Patients with a current or a history of drug allergy to PPI.
  • Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Unknown Facility

Kariya, Aichi-ken, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Seto, Aichi-ken, Japan

Location

Unknown Facility

Toyoake, Aichi-ken, Japan

Location

Unknown Facility

Toyohashi, Aichi-ken, Japan

Location

Unknown Facility

Akita, Akira, Japan

Location

Unknown Facility

Urayasu, Chiba, Japan

Location

Unknown Facility

Niihama, Ehime, Japan

Location

Unknown Facility

Chikushino-shi, Fukoka, Japan

Location

Unknown Facility

Fukoka, Fukoka, Japan

Location

Unknown Facility

Kurume, Fukoka, Japan

Location

Unknown Facility

Oumuta, Fukoka, Japan

Location

Unknown Facility

Tagawa, Fukoka, Japan

Location

Unknown Facility

Sabae, Fukui, Japan

Location

Unknown Facility

Hashima, Gifu, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Miki, Hyōgo, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, Japan

Location

Unknown Facility

Kumamotoi, Kumamoto, Japan

Location

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Sendai, Miyagi, Japan

Location

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Kashihara, Nara, Japan

Location

Unknown Facility

Nigata, Niigata, Japan

Location

Unknown Facility

Yufu, Oita Prefecture, Japan

Location

Unknown Facility

Ikeda, Osaka, Japan

Location

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Izumisano, Osaka, Japan

Location

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Kadoma, Osaka, Japan

Location

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Takatsuki, Osaka, Japan

Location

Unknown Facility

Hasuda, Saitama, Japan

Location

Unknown Facility

Kitaadachi-gun, Saitama, Japan

Location

Unknown Facility

Matsue, Shimane, Japan

Location

Unknown Facility

Hamamatsu, Shizouka, Japan

Location

Unknown Facility

Minato-ku, Tokyo, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, Japan

Location

Unknown Facility

Shinjyuku-ku, Tokyo, Japan

Location

Unknown Facility

Shimonoseki, Yamaguchi, Japan

Location

Unknown Facility

Gifu, Japan

Location

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Hiroshima, Japan

Location

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Kouchi, Japan

Location

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Kyoto, Japan

Location

Unknown Facility

Nara, Japan

Location

Unknown Facility

Ōita, Japan

Location

Unknown Facility

Saga, Japan

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Toshihisa Arai

    GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 2, 2005

Study Start

August 1, 2005

Primary Completion

April 19, 2007

Study Completion

April 19, 2007

Last Updated

October 29, 2018

Record last verified: 2010-01

Locations

JP(43)