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

NCT ID: NCT02135107

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 517 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-06-30

Brief 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.

Detailed 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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A

Group Type: EXPERIMENTAL

Rabeprazole

Intervention Type: DRUG

Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).

Arm B

Group Type: EXPERIMENTAL

Rabeprazole

Intervention Type: DRUG

Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).

Arm C

Group Type: EXPERIMENTAL

Rabeprazole

Intervention Type: DRUG

Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).

Arm D

Group Type: EXPERIMENTAL

Rabeprazole

Intervention Type: DRUG

Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).

Interventions

Rabeprazole

Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).

Intervention Type: DRUG

Rabeprazole

Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).

Intervention Type: DRUG

Rabeprazole

Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).

Intervention Type: DRUG

Rabeprazole

Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).

Intervention Type: DRUG

Other Intervention Names

E3810; E3810; E3810; E3810

Eligibility Criteria

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 through endoscopic examination to have mucosal lesions (erosions, ulcers)

2. Patients shown through endoscopy not to have recovered despite administration of PPI once daily for eight weeks.

3. Patients over 20 years of age who have freely given their informed consent in writing to participation in the study.

4. Patients who, having received a full explanation of the matters that must be adhered to during the study, intend to adhere to their requirements, and are capable of doing so.

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 gastrointestinal tract 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, hematological disorders, 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 weeks prior to enrollment.

9. Patients who are, or may be pregnant, patients who wish to become pregnant during the study period, patients who are breastfeeding, and patients or their partners who do not wish to use reliable contraceptive measures.

10. Patients with a history of dependence on or abuse of drugs or alcohol within the past two years.

11. Other patients deemed unsuitable for inclusion in the study by the principal investigator or sub-investigators.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya, Aichi-ken, Japan

Inzai, Chiba, Japan

Kamagaya, Chiba, Japan

Matsuyama, Ehime, Japan

Kitakyushu, Fukuoka, Japan

Koga, Fukuoka, Japan

Kōriyama, Fukushima, Japan

Annaka, Gunma, Japan

Fukuyama, Hiroshima, Japan

Asahikawa, Hokkaido, Japan

Ishikari, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Amagasaki, Hyōgo, Japan

Kobe, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Furukawa, Ibaraki, Japan

Tsuchiura, Ibaraki, Japan

Takamatsu, Kagawa-ken, Japan

Ichikikushikino-shi, Kagoshima-ken, Japan

Kamakura, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Sendai, Miyagi, Japan

Suwa, Nagano, Japan

Beppu, Oita Prefecture, Japan

Fujiidera, Osaka, Japan

Hirakata, Osaka, Japan

Kishiwada, Osaka, Japan

Takatsuki, Osaka, Japan

Karatsu, Saga-ken, Japan

Ureshino, Saga-ken, Japan

Ageo, Saitama, Japan

Hiki, Saitama, Japan

Toda, Saitama, Japan

Wako, Saitama, Japan

Izumo, Shimane, Japan

Fujieda, Shizuoka, Japan

Hamamatsu, Shizuoka, Japan

Ōtawara, Tochigi, Japan

Adachi City, Tokyo, Japan

Bunkyo, Tokyo, Japan

Chūō, Tokyo, Japan

Koto, Tokyo, Japan

Minato, Tokyo, Japan

Nerima City, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya City, Tokyo, Japan

Shibuya City, Tokyo, Japan

Shinagawa, Tokyo, Japan

Toshima City, Tokyo, Japan

Akita, , Japan

Fukuoka, , Japan

Hiroshima, , Japan

Kochi, , Japan

Kyoto, , Japan

Nagasaki, , Japan

Osaka, , Japan

Ōita, , Japan

Saga, , Japan

Saitama, , Japan

Yamagata, , Japan

Countries

Japan

References

Kinoshita Y, Kato M, Fujishiro M, Masuyama H, Nakata R, Abe H, Kumagai S, Fukushima Y, Okubo Y, Hojo S, Kusano M. Efficacy and safety of twice-daily rabeprazole maintenance therapy for patients with reflux esophagitis refractory to standard once-daily proton pump inhibitor: the Japan-based EXTEND study. J Gastroenterol. 2018 Jul;53(7):834-844. doi: 10.1007/s00535-017-1417-z. Epub 2017 Nov 29.

Reference Type: DERIVED

PMID: 29188387 (View on PubMed)

Other Identifiers

E3810-J081-311

Identifier Type: -

Identifier Source: org_study_id