Refractory Reflux EsophagitisNCT01321567
Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
An observational study of Refractory Reflux Esophagitis, run by Eisai Co., Ltd. at 447 sites in Japan.
Trial summary
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Reflux Esophagitis
- What is being tested?
- rabeprazole sodium
- Type of treatment
- Pill or oral medicine
- How many people
- 2,157 participants
- Where
- 447 sitesJapan
- Study dates
- 1 Jan 2011to 1 Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitals and Clinics in Japan
Who may be able to join
- -Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)
Who cannot join
- Patients with a history of hypersensitivity to any ingredients of PARIET.
- Patients on atazanavir sulfate.
Trial locations and contacts
447 sites in 1 country.
300 sites in 1 country
Japan300 sites
Study site
Abashiri, Hokkaido
Study site
Abuta, Hokkaido
Study site
Adachi City, Tokyo
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Agatsuma, Gunma
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Ageo, Saitama
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Aichi
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Aioi, Hyōgo
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Aira, Kagoshima-ken
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Aisai, Aichi-ken
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Akaiwa, Okayama-ken
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Akashi, Hyōgo
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Aki, Hiroshima
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Akiruno, Tokyo
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Akishima, Tokyo
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Akita
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Ako, Hyōgo
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Amagasaki, Hyōgo
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Anan, Tokushima
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Anjo, Aichi-ken
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Aomori
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Asahi, Chiba
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Asahikawa, Hokkaido
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Asakuchi, Okayama-ken
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Asakura, Fukuoka
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Ashigarashimo, Kanagawa
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Ashiya, Hyōgo
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Aso, Kumamoto
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Atsugi, Kanagawa
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Awa, Tokushima
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Awaji, Hyōgo
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Bandō, Ibaraki
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Bizen, Okayama-ken
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Bunkyo, Tokyo
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Buzen, Fukuoka
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Chiba
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Chichibu, Saitama
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Chigasaki, Kanagawa
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Chikushi, Fukuoka
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Chikushino-shi, Fukuoka
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Chiyoda City, Tokyo
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Choshi, Chiba
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Chūō, Tokyo
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Chūō, Yamanashi
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Daisen, Akita
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Daitō, Osaka
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Date, Hokkaido
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Ebetsu, Hokkaido
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Ebino, Miyazaki
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Edogawa City, Tokyo
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Eniwa, Hokkaido
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Fuchū, Tokyo
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Fuefuki, Yamanashi
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Fuji, Shizuoka
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Fujieda, Shizuoka
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Fujiidera, Osaka
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Fujimi, Saitama
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Fujinomiya, Shizuoka
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Fujisawa, Kanagawa
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Fukagawa, Hokkaido
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Fukaya, Saitama
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Fukuchiyama, Kyoto
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Fukui
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Fukuoka
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Fukuroi, Shizuoka
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Fukushima
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Fukuyama, Hiroshima
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Funabashi, Chiba
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Furano, Hokkaido
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Gamagōri, Aichi-ken
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Gifu
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Gobō, Wakayama
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Gojō, Nara
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Goshogawara, Aomori
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Hachinohe, Aomori
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Hachiōji, Tokyo
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Hadano, Kanagawa
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Hagi, Yamaguchi
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Hakodate, Hokkaido
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Hakui, Ishikawa-ken
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Hakusan, Ishikawa-ken
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Hamamatsu, Shizuoka
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Hanamaki, Iwate
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Hannō, Saitama
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Hashima, Gifu
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Hidaka, Saitama
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Higashihiroshima, Hiroshima
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Higashimurayama, Tokyo
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Higashimuro, Wakayama
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Higashiokitama, Yamagata
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Higashiosaka, Osaka
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Higashiyamato, Tokyo
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Hikari, Yamaguchi
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Himeji, Hyōgo
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Hino, Tokyo
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Hirakata, Osaka
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Hiratsuka, Kanagawa
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Hirosaki, Aomori
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Hiroshima
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Hitachi, Ibaraki
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Hitachiota, Ibaraki
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Hitoyoshi, Kumamoto
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Hokota, Ibaraki
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Hokuto, Hokkaido
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Hyūga, Miyazaki
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Ibaraki, Osaka
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Ichihara, Chiba
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Ichikawa, Chiba
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Ichikikushikino, Kagoshima-ken
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Ichinomiya, Aichi-ken
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Ichinoseki, Iwate
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Iga, Mie-ken
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Ikoma, Nara
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Imabari, Ehime
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Imari, Saga-ken
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Imizu, Toyama
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Ina, Nagano
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Inagi, Tokyo
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Inuyama, Aichi-ken
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Isa, Kagoshima-ken
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Isahaya, Nagasaki
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Ise, Mie-ken
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Isehara, Kanagawa
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Ishikari, Hokkaido
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Ishioka, Ibaraki
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Isshōchi, Kumamoto
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Itako, Ibaraki
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Itami, Hyōgo
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Itō, Shizuoka
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Itoman, Okinawa
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Iwade, Wakayama
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Iwaki, Fukushima
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Iwakuni, Yamaguchi
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Iwata, Shizuoka
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Izumi, Kagoshima-ken
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Izumi, Osaka
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Izumiōtsu, Osaka
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Izumisano, Osaka
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Izumo, Shimane
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Jōetsu, Niigata
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Jōsō, Ibaraki
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Kadoma, Osaka
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Kagoshima
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Kahoku, Ishikawa-ken
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Kainan, Wakayama
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Kakamigahara, Gifu
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Kakogawa, Hyōgo
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Kamakura, Kanagawa
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Kameoka, Kyoto
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Kameyama, Mie-ken
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Kamiina, Nagano
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Kamiiso, Hokkaido
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Kamimashiki, Kumamoto
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Kaminoyama, Yamagata
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Kan’onjichō, Kagawa-ken
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Kanazawa, Ishikawa-ken
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Kanoya, Kagoshima-ken
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Kanzaki, Saga-ken
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Kariya, Aichi-ken
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Kasai, Hokkaido
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Kashihara, Nara
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Kashiwa, Chiba
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Kashiwazaki, Niigata
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Kasuga, Fukuoka
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Kasugai, Aichi-ken
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Kasukabe, Saitama
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Katano, Osaka
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Kato, Hokkaido
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Katori-shi, Chiba
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Katsushika-ku, Tokyo
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Kawagoe, Saitama
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Kawaguchi, Saitama
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Kawasaki, Kanagawa
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Kayabe, Hokkaido
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Kazo, Saitama
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Kikugawa, Shizuoka
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Kirishima, Kagoshima-ken
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Kiryū, Gunma
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Kishiwada, Osaka
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Kiso, Nagano
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Kita-ku, Tokyo
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Kitaadachi, Saitama
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Kitaibaraki, Ibaraki
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Kitakatsuragi, Nara
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Kitakyushu, Fukuoka
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Kitami, Hokkaido
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Kitamuro, Mie-ken
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Kitatsugaru, Aomori
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Kitauwa, Ehime
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Kobe, Hyōgo
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Kochi
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Kodaira, Tokyo
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Kofu, Yamanashi
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Koga, Ibaraki
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Koganei, Tokyo
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Kōka, Shiga
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Komagane, Nagano
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Kōriyama, Fukushima
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Kōshi, Kumamoto
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Koshigaya, Saitama
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Kōshū, Yamanashi
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Koto, Tokyo
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Koyu, Miyazaki
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Kukichūō, Saitama
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Kumage, Kagoshima-ken
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Kumamoto
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Kunisaki, Oita Prefecture
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Kurashiki, Okayama-ken
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Kurayoshi, Tottori
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Kure, Hiroshima
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Kurobe-shi, Toyama
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Kurume, Fukuoka
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Kusatsu, Shiga
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Kushima, Miyazaki
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Kushiro, Hokkaido
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Kuwana, Mie-ken
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Kyōtango, Kyoto
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Kyoto
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Machida, Tokyo
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Maebashi, Gunma
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Maizuru, Kyoto
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Marugame, Kagawa-ken
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Matsubara, Osaka
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Matsudo, Chiba
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Matsue, Shimane
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Matsumoto, Nagano
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Matsusaka, Mie-ken
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Matsuyama, Ehime
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Meguro City, Tokyo
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Midori, Gunma
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Mie
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Mihara, Hiroshima
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Mikatakaminaka, Fukui
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Miki, Hyōgo
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Minami-Alps, Yamanashi
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Minamiashigara, Kanagawa
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Minamikawachi, Osaka
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Minamikoma, Yamanashi
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Minamiuonuma, Niigata
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Minato, Tokyo
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Mino, Osaka
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Minokamo, Gifu
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Mishima, Shizuoka
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Mitaka, Tokyo
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Mito, Ibaraki
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Mitoyo, Kagawa-ken
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Mitsuke, Niigata
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Miyakonojō, Miyazaki
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Miyama, Fukuoka
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Miyazaki
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Miyoshi, Hiroshima
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Mizunami, Gifu
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Mobara, Chiba
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Mooka, Tochigi
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Moriguchi, Osaka
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Morioka, Iwate
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Moriya, Ibaraki
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Moriyama, Shiga
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Mukō, Kyoto
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Munakata, Fukuoka
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Muroran, Hokkaido
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Mutsu, Aomori
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Myozai, Tokushima
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Nagahama, Shiga
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Nagano
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Nagaoka, Niigata
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Nagasaki
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Nago, Okinawa
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Nagoya, Aichi-ken
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Naka, Ibaraki
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Naka, Kanagawa
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Nakagami, Okinawa
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Nakagawa, Hokkaido
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Nakaniikawa, Toyama
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Nakano, Nagano
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Nakano City, Tokyo
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Nakatsu, Oita Prefecture
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Namerikawa, Toyama
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Nantan, Kyoto
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Nanto, Toyama
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Nara
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Narashino, Chiba
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Narutochō-mitsuishi, Tokushima
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Nerima City, Tokyo
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Neyagawa, Osaka
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Niigata
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Niihama, Ehime
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Niimi, Okayama-ken
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Nikkō, Tochigi
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Nishimuro, Wakayama
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Nishinomiya, Hyōgo
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Nishitōkyō, Tokyo
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Nobeoka, Miyazaki
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Noda, Chiba
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Nōgata, Fukuoka
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Nomi, Ishikawa-ken
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Numazu, Shizuoka
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Obihiro, Hokkaido
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Odawara, Kanagawa
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Ōgaki, Gifu
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Ogi, Saga-ken
About this study
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis
- Conditions
- Refractory Reflux Esophagitis
- Being tested
- rabeprazole sodium
- Keywords
- rabeprazole sodium, refractory reflux esophagitis
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazole sodiumDrug
Doses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.
| Study group | Role | What they receive |
|---|---|---|
| Rabeprazole Sodium | Not described Receives: Drug: rabeprazole sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire
Measured: Check at predose, 4, 8, 16 and 32 weeks
Secondary outcomes (3)
Number of subjects with improvement in symptoms of GERD
Measured: Check at predose, 4, 8, 16 and 32 weeks
Endoscopic healing rate
Measured: 8 weeks
Adverse events
Measured: Every 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study start1 Jan 2011
- Primary completion1 Mar 2013
- Study completion1 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory Reflux EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshinori Furuhata, Study director, Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321567
- Sponsor's protocol ID
- PRT11T
- Status last verified
- May 2015
- First submitted
- 18 Mar 2011
- Last updated
- 24 Jul 2023
- Results posted
- No
Publications
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.
PubMed 28502925
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT01321567
- Acronym / sponsor ID
- PRT11T
- Conditions
- Refractory Reflux Esophagitis
- Keywords
- rabeprazole sodium, refractory reflux esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,157 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 1 Aug 2013 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rabeprazole Sodium | – | Drug: rabeprazole sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitals and Clinics in Japan
Key inclusion criteria (1 listed)
- -Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to any ingredients of PARIET.
- Patients on atazanavir sulfate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rabeprazole sodiumDoses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury. | Drug | Rabeprazole Sodium |
Primary outcome
Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire
Time frame: Check at predose, 4, 8, 16 and 32 weeks
3 secondary outcomes
Number of subjects with improvement in symptoms of GERD
Time frame: Check at predose, 4, 8, 16 and 32 weeks
Endoscopic healing rate
Time frame: 8 weeks
Adverse events
Time frame: Every 4-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 28502925Kinoshita 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshinori Furuhata study director
Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.
447 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Reflux Esophagitis, run by Eisai Co., Ltd. at 447 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 447 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire (time frame: Check at predose, 4, 8, 16 and 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.