A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

Last updated: June 16, 2023
Sponsor: Eisai Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

Rabeprazole

Clinical Study ID

NCT02135107
E3810-J081-311
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects fulfilling all of the below criteria shall be eligible for the study:

  1. Patients diagnosed with gastroesophageal reflux disease who are shown throughendoscopic examination to have mucosal lesions (erosions, ulcers)
  2. Patients shown through endoscopy not to have recovered despite administration of PPIonce daily for eight weeks.
  3. Patients over 20 years of age who have freely given their informed consent in writingto participation in the study.
  4. Patients who, having received a full explanation of the matters that must be adheredto during the study, intend to adhere to their requirements, and are capable of doingso.

Exclusion

Exclusion Criteria: Subjects fulfilling any of the following criteria shall be excluded from the study:

  1. Patients considered candidates for surgical treatment of the upper gastrointestinaltract due to perforation, esophageal stricture, pyloric stenosis, esophageal varices,etc.
  2. Patients with Zollinger-Ellison syndrome.
  3. Patients with gastrointestinal hemorrhage.
  4. Patients with serious cardiovascular disease, cerebrovascular disease, hematologicaldisorders, renal disease, liver disease, malignant tumors, etc.
  5. Patients with long segment Barrett's esophagus.
  6. Patients with open gastric or duodenal ulcers.
  7. Patients with drug allergies or a past history of drug allergies to PPI.
  8. Patients who are taking other drugs under development, or have done so within 12 weeksprior to enrollment.
  9. Patients who are, or may be pregnant, patients who wish to become pregnant during thestudy period, patients who are breastfeeding, and patients or their partners who donot wish to use reliable contraceptive measures.
  10. Patients with a history of dependence on or abuse of drugs or alcohol within the pasttwo years.
  11. Other patients deemed unsuitable for inclusion in the study by the principalinvestigator or sub-investigators.

Study Design

Total Participants: 517
Treatment Group(s): 1
Primary Treatment: Rabeprazole
Phase: 3
Study Start date:
September 01, 2013
Estimated Completion Date:
June 30, 2016

Study Description

This is randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks. The 8-week Treatment Period (unblinded) was followed by a 52-week Maintenance Period (blinded). Participants with cure (modified Los Angeles Classification Grade N or Grade M) at the final endoscopy of the Treatment Period were entered into the Maintenance Period. Participants without cure were discontinued from the study. The participants in the Treatment Period were randomized to take Arm C or Arm D at a ratio of 1:1. The non-recurrence rate as endoscopically confirmed at 52 weeks shall be the primary end point, and this shall be examined through a randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks.

Connect with a study center

  • Nagoya, Aichi
    Japan

    Site Not Available

  • Inzai, Chiba
    Japan

    Site Not Available

  • Kamagaya, Chiba
    Japan

    Site Not Available

  • Matsuyama, Ehime
    Japan

    Site Not Available

  • Kitakyushu, Fukuoka
    Japan

    Site Not Available

  • empty

    Kitakyusyu, Fukuoka
    Japan

    Site Not Available

  • Onga, Fukuoka
    Japan

    Site Not Available

  • Koriyama, Fukushima
    Japan

    Site Not Available

  • Annaka, Gunma
    Japan

    Site Not Available

  • Fukuyama, Hiroshima
    Japan

    Site Not Available

  • Asahikawa, Hokkaido
    Japan

    Site Not Available

  • Ishikari, Hokkaido
    Japan

    Site Not Available

  • Sapporo, Hokkaido
    Japan

    Site Not Available

  • Amagasaki, Hyogo
    Japan

    Site Not Available

  • Kobe, Hyogo
    Japan

    Site Not Available

  • Nishinomiya, Hyogo
    Japan

    Site Not Available

  • Furukawa, Ibaraki
    Japan

    Site Not Available

  • Tsuchiura, Ibaraki
    Japan

    Site Not Available

  • Takamatsu, Kagawa
    Japan

    Site Not Available

  • Ichikikushikino-shi, Kagoshima
    Japan

    Site Not Available

  • Kamakura, Kanagawa
    Japan

    Site Not Available

  • Kawasaki, Kanagawa
    Japan

    Site Not Available

  • Yokohama, Kanagawa
    Japan

    Site Not Available

  • Sendai, Miyagi
    Japan

    Site Not Available

  • Suwa, Nagano
    Japan

    Site Not Available

  • Beppu, Oita
    Japan

    Site Not Available

  • Fujiidera, Osaka
    Japan

    Site Not Available

  • Hirakata, Osaka
    Japan

    Site Not Available

  • Kishiwada, Osaka
    Japan

    Site Not Available

  • Takatsuki, Osaka
    Japan

    Site Not Available

  • Karatsu, Saga
    Japan

    Site Not Available

  • Ureshino, Saga
    Japan

    Site Not Available

  • Ageo, Saitama
    Japan

    Site Not Available

  • Hiki, Saitama
    Japan

    Site Not Available

  • Toda, Saitama
    Japan

    Site Not Available

  • Wako, Saitama
    Japan

    Site Not Available

  • Izumo, Shimane
    Japan

    Site Not Available

  • Fujieda, Shizuoka
    Japan

    Site Not Available

  • Hamamatsu, Shizuoka
    Japan

    Site Not Available

  • empty

    Ohtawara, Tochigi
    Japan

    Site Not Available

  • Ōtawara, Tochigi
    Japan

    Site Not Available

  • Adachi, Tokyo
    Japan

    Site Not Available

  • Bunkyo, Tokyo
    Japan

    Site Not Available

  • Chuo, Tokyo
    Japan

    Site Not Available

  • Koto, Tokyo
    Japan

    Site Not Available

  • Minato, Tokyo
    Japan

    Site Not Available

  • Nerima, Tokyo
    Japan

    Site Not Available

  • Ota, Tokyo
    Japan

    Site Not Available

  • Setagaya, Tokyo
    Japan

    Site Not Available

  • Shibuya, Tokyo
    Japan

    Site Not Available

  • Shinagawa, Tokyo
    Japan

    Site Not Available

  • Toshima, Tokyo
    Japan

    Site Not Available

  • Akita,
    Japan

    Site Not Available

  • Fukuoka,
    Japan

    Site Not Available

  • Hiroshima,
    Japan

    Site Not Available

  • Kochi,
    Japan

    Site Not Available

  • Kyoto,
    Japan

    Site Not Available

  • Nagasaki,
    Japan

    Site Not Available

  • Oita,
    Japan

    Site Not Available

  • Osaka,
    Japan

    Site Not Available

  • Saga,
    Japan

    Site Not Available

  • Saitama,
    Japan

    Site Not Available

  • Yamagata,
    Japan

    Site Not Available

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