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A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium

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: NCT00125736
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Stomach Ulcer Drug: E0671 Drug: rabeprazole sodium Drug: E0671 placebo Phase 4

Detailed Description:
The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
Actual Study Start Date : August 1, 2005
Actual Primary Completion Date : April 19, 2007
Actual Study Completion Date : April 19, 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: E0671 combination group Drug: E0671
One 50 mg capsule is orally administered three times daily (150 mg/day)

Drug: rabeprazole sodium
One 10mg tablet is administered orally each day

Placebo Comparator: placebo combination group Drug: rabeprazole sodium
One 10mg tablet is administered orally each day

Drug: E0671 placebo
One 50 mg capsule is orally administered three times daily (150 mg/day)




Primary Outcome Measures :
  1. Ratio of S2-stage transition at 8 weeks after the study administration. [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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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:

  1. Patients with gastric ulcer (A1-and A2-stage)
  2. 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
  3. Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.

Exclusion criteria:

  1. Patients with a complication of duodenal ulcer (excluding cicatrix).
  2. Patients with reflux esophagitis
  3. Patients with acute gastric mucosal lesions (AGML).
  4. Patients with NSAID-induced ulcer.
  5. Patients with linear ulcer.
  6. Patients with ulcer injured by endoscopy.
  7. Patients who underwent gastrectomy or vagal nerve resection.
  8. Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc.
  9. Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration.
  10. 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.
  11. Patients with a current or a history of drug allergy to teprenone preparation(s).
  12. Patients with a current or a history of drug allergy to PPI.
  13. Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.

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): NCT00125736


Locations
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Japan
Kariya, Aichi, Japan
Nagoya, Aichi, Japan
Seto, Aichi, Japan
Toyoake, Aichi, Japan
Toyohashi, Aichi, Japan
Akita, Akira, Japan
Urayasu, Chiba, Japan
Niihama, Ehime, Japan
Chikushino, Fukoka, Japan
Kurume, Fukoka, Japan
Oumuta, Fukoka, Japan
Tagawa, Fukoka, Japan
Sabae, Fukui, Japan
Hashima, Gifu, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Miki, Hyogo, Japan
Kanazawa, Ishikawa, Japan
Kumamotoi, Kumamoto, Japan
Sendai, Miyagi-prefecture, Japan
Kashihara, Nara, Japan
Yufu, Oita, Japan
Ikeda, Osaka, Japan
Izumisano, Osaka, Japan
Kadoma, Osaka, Japan
Takatsuki, Osaka, Japan
Hasuda, Saitama, Japan
Kitaadachi-gun, Saitama, Japan
Matue, Shimane, Japan
Hamamatsu, Shizouka, Japan
Minato-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjyuku-ku, Tokyo, Japan
Shimonoseki, Yamaguchi, Japan
Fukoka, Japan
Gifu, Japan
Hiroshima, Japan
Kouchi, Japan
Kyoto, Japan
Nara, Japan
Nigata, Japan
Oita, Japan
Saga, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Toshihisa Arai GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00125736    
Other Study ID Numbers: E0671-J081-291
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: January 2010
Additional relevant MeSH terms:
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Stomach Ulcer
Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action