Clinical trial NCT00125736: A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
Official title: A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stomach Ulcer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-02
Enrollment: 520
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: Ratio of S2-stage transition at 8 weeks after the study administration.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kariya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Seto
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Akita
country: Japan
state: Akira
city: Urayasu
country: Japan
state: Chiba
city: Niihama
country: Japan
state: Ehime
city: Chikushino
country: Japan
state: Fukoka
city: Kurume
country: Japan
state: Fukoka
city: Oumuta
country: Japan
state: Fukoka
city: Tagawa
country: Japan
state: Fukoka
city: Sabae
country: Japan
state: Fukui
city: Hashima
country: Japan
state: Gifu
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Miki
country: Japan
state: Hyogo
city: Kanazawa
country: Japan
state: Ishikawa
city: Kumamotoi
country: Japan
state: Kumamoto
city: Sendai
country: Japan
state: Miyagi-prefecture
city: Kashihara
country: Japan
state: Nara
city: Yufu
country: Japan
state: Oita
city: Ikeda
country: Japan
state: Osaka
city: Izumisano
country: Japan
state: Osaka
city: Kadoma
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Hasuda
country: Japan
state: Saitama
city: Kitaadachi-gun
country: Japan
state: Saitama
city: Matue
country: Japan
state: Shimane
city: Hamamatsu
country: Japan
state: Shizouka
city: Minato-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjyuku-ku
country: Japan
state: Tokyo
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Fukoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kouchi
country: Japan
city: Kyoto
country: Japan
city: Nara
country: Japan
city: Nigata
country: Japan
city: Oita
country: Japan
city: Saga
country: Japan
Study officials:
affiliation: GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center
name: Toshihisa Arai
role: STUDY_DIRECTOR
References: