Clinical trial NCT02135107: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 517
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 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.

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.

Primary outcomes:
measure: Rate of Non-recurrence at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Rate of Non-recurrence at Weeks 12 and 24
timeFrame: Weeks 12 and 24
measure: Cumulative Non-recurrence Rate at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
timeFrame: From Week 4 up to Week 52
measure: Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
timeFrame: From Week 4 up to Week 52
measure: Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
timeFrame: From Week 4 up to Week 52
measure: Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period
timeFrame: From Week 4 up to Week 52
measure: Frequency of Sleep Disorders During the Maintenance Therapy Period
timeFrame: From Week 4 up to Week 52
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Inzai
country: Japan
state: Chiba
city: Kamagaya
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Kitakyushu
country: Japan
state: Fukuoka
city: Onga
country: Japan
state: Fukuoka
city: Koriyama
country: Japan
state: Fukushima
city: Annaka
country: Japan
state: Gunma
city: Fukuyama
country: Japan
state: Hiroshima
city: Asahikawa
country: Japan
state: Hokkaido
city: Ishikari
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Furukawa
country: Japan
state: Ibaraki
city: Tsuchiura
country: Japan
state: Ibaraki
city: Takamatsu
country: Japan
state: Kagawa
city: Ichikikushikino-shi
country: Japan
state: Kagoshima
city: Kamakura
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Suwa
country: Japan
state: Nagano
city: Beppu
country: Japan
state: Oita
city: Fujiidera
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Karatsu
country: Japan
state: Saga
city: Ureshino
country: Japan
state: Saga
city: Ageo
country: Japan
state: Saitama
city: Hiki
country: Japan
state: Saitama
city: Toda
country: Japan
state: Saitama
city: Wako
country: Japan
state: Saitama
city: Izumo
country: Japan
state: Shimane
city: Fujieda
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Ōtawara
country: Japan
state: Tochigi
city: Adachi
country: Japan
state: Tokyo
city: Bunkyo
country: Japan
state: Tokyo
city: Chuo
country: Japan
state: Tokyo
city: Koto
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Nerima
country: Japan
state: Tokyo
city: Ota
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shibuya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Toshima
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Fukuoka
country: Japan
city: Hiroshima
country: Japan
city: Kochi
country: Japan
city: Kyoto
country: Japan
city: Nagasaki
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Yamagata
country: Japan
Study officials:
References:
citation: 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.