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

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

Study Description

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).

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Toshihisa Arai; GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

More Information

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00125736
• Other Study ID Numbers: E0671-J081-291
• First Posted: August 2, 2005
• Last Update Posted: October 29, 2018
• Last Verified: January 2010

Additional relevant MeSH terms:

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