Clinical trial NCT01321567: Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
Official title: Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Reflux Esophagitis
Keywords: rabeprazole sodium
refractory reflux esophagitis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 2157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals and Clinics in Japan

Brief summary: To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis


Eligibility criteria: Inclusion criteria;

-Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)

Exclusion criteria;

* Patients with a history of hypersensitivity to any ingredients of PARIET.
* Patients on atazanavir sulfate.

Primary outcomes:
measure: Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire
timeFrame: Check at predose, 4, 8, 16 and 32 weeks
Secondary outcomes:
measure: Number of subjects with improvement in symptoms of GERD
timeFrame: Check at predose, 4, 8, 16 and 32 weeks
measure: Endoscopic healing rate
timeFrame: 8 weeks
measure: Adverse events
timeFrame: Every 4-8 weeks
Other outcomes:
Locations:
city: Aisai
country: Japan
state: Aichi
city: Anjo
country: Japan
state: Aichi
city: Gamagori
country: Japan
state: Aichi
city: Ichinomiya
country: Japan
state: Aichi
city: Inuyama
country: Japan
state: Aichi
city: Kariya
country: Japan
state: Aichi
city: Kasugai
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Owariasahi
country: Japan
state: Aichi
city: Tokai
country: Japan
state: Aichi
city: Tokoname
country: Japan
state: Aichi
city: Toyota
country: Japan
state: Aichi
city: Tsushima
country: Japan
state: Aichi
city: Daisen
country: Japan
state: Akita
city: Yokote
country: Japan
state: Akita
city: Yurihonjo
country: Japan
state: Akita
city: Goshogawara
country: Japan
state: Aomori
city: Hachinohe
country: Japan
state: Aomori
city: Hirosaki
country: Japan
state: Aomori
city: Kitatsugaru
country: Japan
state: Aomori
city: Mutsu
country: Japan
state: Aomori
city: Sannohe
country: Japan
state: Aomori
city: Towada
country: Japan
state: Aomori
city: Asahi
country: Japan
state: Chiba
city: Choshi
country: Japan
state: Chiba
city: Funabashi
country: Japan
state: Chiba
city: Ichihara
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Katori
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Mobara
country: Japan
state: Chiba
city: Narashino
country: Japan
state: Chiba
city: Noda
country: Japan
state: Chiba
city: Imabari
country: Japan
state: Ehime
city: Kitauwa
country: Japan
state: Ehime
city: Matsuyama
country: Japan
state: Ehime
city: Niihama
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state: Ehime
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country: Japan
state: Ehime
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state: Ehime
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country: Japan
state: Ehime
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country: Japan
state: Fukui
city: Ono
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state: Fukui
city: Sabae
country: Japan
state: Fukui
city: Sakai
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state: Fukui
city: Asakura
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state: Fukuoka
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state: Fukuoka
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state: Fukuoka
city: Chikushino
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state: Fukuoka
city: Chikushi
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state: Fukuoka
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state: Fukuoka
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country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Mie
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokushima
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
city: Yamagata
country: Japan
city: Yamanashi
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.
name: Yoshinori Furuhata
role: STUDY_DIRECTOR
References:
citation: Kinoshita Y, Hongo M, Kusano M, Furuhata Y, Miyagishi H, Ikeuchi S; RPZ Study Group. Therapeutic Response to Twice-daily Rabeprazole on Health-related Quality of Life and Symptoms in Patients with Refractory Reflux Esophagitis: A Multicenter Observational Study. Intern Med. 2017;56(10):1131-1139. doi: 10.2169/internalmedicine.56.7896. Epub 2017 May 15.