Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis

NCT ID: NCT01321567

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2013-08-01

Brief Summary

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rabeprazole Sodium

rabeprazole sodium

Intervention Type: DRUG

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.

Interventions

rabeprazole sodium

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshinori Furuhata

Role: STUDY_DIRECTOR

Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.

Locations

Aisai, Aichi-ken, Japan

Anjo, Aichi-ken, Japan

Gamagōri, Aichi-ken, Japan

Ichinomiya, Aichi-ken, Japan

Inuyama, Aichi-ken, Japan

Kariya, Aichi-ken, Japan

Kasugai, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Okazaki, Aichi-ken, Japan

Owariasahi, Aichi-ken, Japan

Tokoname, Aichi-ken, Japan

Toyota, Aichi-ken, Japan

Tōkai, Aichi-ken, Japan

Tsushima, Aichi-ken, Japan

Daisen, Akita, Japan

Yokote, Akita, Japan

Yurihonjō, Akita, Japan

Goshogawara, Aomori, Japan

Hachinohe, Aomori, Japan

Hirosaki, Aomori, Japan

Kitatsugaru, Aomori, Japan

Mutsu, Aomori, Japan

Sannohe, Aomori, Japan

Towada, Aomori, Japan

Asahi, Chiba, Japan

Choshi, Chiba, Japan

Funabashi, Chiba, Japan

Ichihara, Chiba, Japan

Ichikawa, Chiba, Japan

Kashiwa, Chiba, Japan

Katori-shi, Chiba, Japan

Matsudo, Chiba, Japan

Mobara, Chiba, Japan

Narashino, Chiba, Japan

Noda, Chiba, Japan

Imabari, Ehime, Japan

Kitauwa, Ehime, Japan

Matsuyama, Ehime, Japan

Niihama, Ehime, Japan

Ōzu, Ehime, Japan

Saijō, Ehime, Japan

Uwajima, Ehime, Japan

Mikatakaminaka, Fukui, Japan

Ono, Fukui, Japan

Sabae, Fukui, Japan

Sakai, Fukui, Japan

Asakura, Fukuoka, Japan

Buzen, Fukuoka, Japan

Chikushi, Fukuoka, Japan

Chikushino-shi, Fukuoka, Japan

Kasuga, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Miyama, Fukuoka, Japan

Munakata, Fukuoka, Japan

Nōgata, Fukuoka, Japan

Omuta, Fukuoka, Japan

Ōkawa, Fukuoka, Japan

Tagawa, Fukuoka, Japan

Tsuiki, Fukuoka, Japan

Wakasugi, Fukuoka, Japan

Yame, Fukuoka, Japan

Iwaki, Fukushima, Japan

Kōriyama, Fukushima, Japan

Shirakawa, Fukushima, Japan

Sōma, Fukushima, Japan

Yama, Fukushima, Japan

Hashima, Gifu, Japan

Kakamigahara, Gifu, Japan

Minokamo, Gifu, Japan

Mizunami, Gifu, Japan

Ōgaki, Gifu, Japan

Sekimachi, Gifu, Japan

Tajimi, Gifu, Japan

Takayama, Gifu, Japan

Agatsuma, Gunma, Japan

Kiryū, Gunma, Japan

Maebashi, Gunma, Japan

Midori, Gunma, Japan

Ōta, Gunma, Japan

Takasaki, Gunma, Japan

Aki, Hiroshima, Japan

Fukuyama, Hiroshima, Japan

Higashihiroshima, Hiroshima, Japan

Kure, Hiroshima, Japan

Mihara, Hiroshima, Japan

Miyoshi, Hiroshima, Japan

Onomichi, Hiroshima, Japan

Takehara, Hiroshima, Japan

Abashiri, Hokkaido, Japan

Abuta, Hokkaido, Japan

Asahikawa, Hokkaido, Japan

Date, Hokkaido, Japan

Ebetsu, Hokkaido, Japan

Eniwa, Hokkaido, Japan

Fukagawa, Hokkaido, Japan

Furano, Hokkaido, Japan

Hakodate, Hokkaido, Japan

Hokuto, Hokkaido, Japan

Ishikari, Hokkaido, Japan

Kamiiso, Hokkaido, Japan

Kasai, Hokkaido, Japan

Kato, Hokkaido, Japan

Kayabe, Hokkaido, Japan

Kitami, Hokkaido, Japan

Kushiro, Hokkaido, Japan

Muroran, Hokkaido, Japan

Nakagawa, Hokkaido, Japan

Obihiro, Hokkaido, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Shibetsu, Hokkaido, Japan

Suttsu, Hokkaido, Japan

Tomakomai, Hokkaido, Japan

Yoichi, Hokkaido, Japan

Aioi, Hyōgo, Japan

Akashi, Hyōgo, Japan

Ako, Hyōgo, Japan

Amagasaki, Hyōgo, Japan

Ashiya, Hyōgo, Japan

Awaji, Hyōgo, Japan

Himeji, Hyōgo, Japan

Itami, Hyōgo, Japan

Kakogawa, Hyōgo, Japan

Kobe, Hyōgo, Japan

Miki, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Ono, Hyōgo, Japan

Sanda, Hyōgo, Japan

Sasayama, Hyōgo, Japan

Sumoto, Hyōgo, Japan

Takarazuka, Hyōgo, Japan

Tamba, Hyōgo, Japan

Bandō, Ibaraki, Japan

Hitachi, Ibaraki, Japan

Hitachiota, Ibaraki, Japan

Hokota, Ibaraki, Japan

Ishioka, Ibaraki, Japan

Itako, Ibaraki, Japan

Jōsō, Ibaraki, Japan

Kitaibaraki, Ibaraki, Japan

Koga, Ibaraki, Japan

Mito, Ibaraki, Japan

Moriya, Ibaraki, Japan

Naka, Ibaraki, Japan

Ryūgasaki, Ibaraki, Japan

Shimo-tsuma, Ibaraki, Japan

Tsukuba, Ibaraki, Japan

Ushiku, Ibaraki, Japan

Hakui, Ishikawa-ken, Japan

Hakusan, Ishikawa-ken, Japan

Kahoku, Ishikawa-ken, Japan

Kanazawa, Ishikawa-ken, Japan

Nomi, Ishikawa-ken, Japan

Hanamaki, Iwate, Japan

Ichinoseki, Iwate, Japan

Morioka, Iwate, Japan

Ōshū, Iwate, Japan

Tōno, Iwate, Japan

Kan’onjichō, Kagawa-ken, Japan

Marugame, Kagawa-ken, Japan

Mitoyo, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Aira, Kagoshima-ken, Japan

Ichikikushikino, Kagoshima-ken, Japan

Isa, Kagoshima-ken, Japan

Izumi, Kagoshima-ken, Japan

Kanoya, Kagoshima-ken, Japan

Kirishima, Kagoshima-ken, Japan

Kumage, Kagoshima-ken, Japan

Sendai, Kagoshima-ken, Japan

Ashigarashimo, Kanagawa, Japan

Atsugi, Kanagawa, Japan

Chigasaki, Kanagawa, Japan

Fujisawa, Kanagawa, Japan

Hadano, Kanagawa, Japan

Hiratsuka, Kanagawa, Japan

Isehara, Kanagawa, Japan

Kamakura, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Minamiashigara, Kanagawa, Japan

Naka, Kanagawa, Japan

Odawara, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Zama, Kanagawa, Japan

Aso, Kumamoto, Japan

Hitoyoshi, Kumamoto, Japan

Isshōchi, Kumamoto, Japan

Kamimashiki, Kumamoto, Japan

Kōshi, Kumamoto, Japan

Yatsushiro, Kumamoto, Japan

Fukuchiyama, Kyoto, Japan

Kameoka, Kyoto, Japan

Kyōtango, Kyoto, Japan

Maizuru, Kyoto, Japan

Mukō, Kyoto, Japan

Nantan, Kyoto, Japan

Yosa, Kyoto, Japan

Iga, Mie-ken, Japan

Ise, Mie-ken, Japan

Kameyama, Mie-ken, Japan

Kitamuro, Mie-ken, Japan

Kuwana, Mie-ken, Japan

Matsusaka, Mie-ken, Japan

Suzuka, Mie-ken, Japan

Tsu, Mie-ken, Japan

Yokkaichi, Mie-ken, Japan

Ōsaki, Miyagi, Japan

Sendai, Miyagi, Japan

Shiroishi, Miyagi, Japan

Toda, Miyagi, Japan

Tome, Miyagi, Japan

Ebino, Miyazaki, Japan

Hyūga, Miyazaki, Japan

Koyu, Miyazaki, Japan

Kushima, Miyazaki, Japan

Miyakonojō, Miyazaki, Japan

Nobeoka, Miyazaki, Japan

Ina, Nagano, Japan

Kamiina, Nagano, Japan

Kiso, Nagano, Japan

Komagane, Nagano, Japan

Matsumoto, Nagano, Japan

Nakano, Nagano, Japan

Saku, Nagano, Japan

Ueda, Nagano, Japan

Isahaya, Nagasaki, Japan

Sasebo, Nagasaki, Japan

Unzen, Nagasaki, Japan

Gojō, Nara, Japan

Ikoma, Nara, Japan

Kashihara, Nara, Japan

Kitakatsuragi, Nara, Japan

Ōuda-yamaguchi, Nara, Japan

Sakurai, Nara, Japan

Tenri, Nara, Japan

Yamatokōriyama, Nara, Japan

Yamatotakada, Nara, Japan

Jōetsu, Niigata, Japan

Kashiwazaki, Niigata, Japan

Minamiuonuma, Niigata, Japan

Mitsuke, Niigata, Japan

Nagaoka, Niigata, Japan

Sado, Niigata, Japan

Shibata, Niigata, Japan

Tōkamachi, Niigata, Japan

Kunisaki, Oita Prefecture, Japan

Nakatsu, Oita Prefecture, Japan

Taketa, Oita Prefecture, Japan

Usa, Oita Prefecture, Japan

Yufu, Oita Prefecture, Japan

Akaiwa, Okayama-ken, Japan

Asakuchi, Okayama-ken, Japan

Bizen, Okayama-ken, Japan

Kurashiki, Okayama-ken, Japan

Niimi, Okayama-ken, Japan

Tsukubo, Okayama-ken, Japan

Tsuyama, Okayama-ken, Japan

Itoman, Okinawa, Japan

Nago, Okinawa, Japan

Nakagami, Okinawa, Japan

Tomigusuku, Okinawa, Japan

Urasoe, Okinawa, Japan

Daitō, Osaka, Japan

Fujiidera, Osaka, Japan

Higashiosaka, Osaka, Japan

Hirakata, Osaka, Japan

Ibaraki, Osaka, Japan

Izumi, Osaka, Japan

Izumiōtsu, Osaka, Japan

Izumisano, Osaka, Japan

Kadoma, Osaka, Japan

Katano, Osaka, Japan

Kishiwada, Osaka, Japan

Matsubara, Osaka, Japan

Minamikawachi, Osaka, Japan

Mino, Osaka, Japan

Moriguchi, Osaka, Japan

Neyagawa, Osaka, Japan

Sakai, Osaka, Japan

Sayama, Osaka, Japan

Sennan, Osaka, Japan

Settsu, Osaka, Japan

Suita, Osaka, Japan

Takaishi, Osaka, Japan

Takatsuki, Osaka, Japan

Tondabayashi, Osaka, Japan

Toyonaka, Osaka, Japan

Yao, Osaka, Japan

Imari, Saga-ken, Japan

Kanzaki, Saga-ken, Japan

Ogi, Saga-ken, Japan

Takeo, Saga-ken, Japan

Taku, Saga-ken, Japan

Tosu, Saga-ken, Japan

Ageo, Saitama, Japan

Chichibu, Saitama, Japan

Fujimi, Saitama, Japan

Fukaya, Saitama, Japan

Hannō, Saitama, Japan

Hidaka, Saitama, Japan

Kasukabe, Saitama, Japan

Kawagoe, Saitama, Japan

Kawaguchi, Saitama, Japan

Kazo, Saitama, Japan

Kitaadachi, Saitama, Japan

Koshigaya, Saitama, Japan

Kukichūō, Saitama, Japan

Sayama, Saitama, Japan

Toda, Saitama, Japan

Tokorozawa, Saitama, Japan

Warabi, Saitama, Japan

Kōka, Shiga, Japan

Kusatsu, Shiga, Japan

Moriyama, Shiga, Japan

Nagahama, Shiga, Japan

Ōtsu, Shiga, Japan

Rittō, Shiga, Japan

Izumo, Shimane, Japan

Matsue, Shimane, Japan

Yasugi, Shimane, Japan

Fuji, Shizuoka, Japan

Fujieda, Shizuoka, Japan

Fujinomiya, Shizuoka, Japan

Fukuroi, Shizuoka, Japan

Hamamatsu, Shizuoka, Japan

Itō, Shizuoka, Japan

Iwata, Shizuoka, Japan

Kikugawa, Shizuoka, Japan

Mishima, Shizuoka, Japan

Numazu, Shizuoka, Japan

Shimada, Shizuoka, Japan

Shimoda, Shizuoka, Japan

Susono, Shizuoka, Japan

Yaizu, Shizuoka, Japan

Mooka, Tochigi, Japan

Nikkō, Tochigi, Japan

Sano, Tochigi, Japan

Shimotsuga, Tochigi, Japan

Utsunomiya, Tochigi, Japan

Anan, Tokushima, Japan

Awa, Tokushima, Japan

Myozai, Tokushima, Japan

Narutochō-mitsuishi, Tokushima, Japan

Okuno, Tokushima, Japan

Adachi City, Tokyo, Japan

Akiruno, Tokyo, Japan

Akishima, Tokyo, Japan

Bunkyo, Tokyo, Japan

Chiyoda City, Tokyo, Japan

Chūō, Tokyo, Japan

Edogawa City, Tokyo, Japan

Fuchū, Tokyo, Japan

Hachiōji, Tokyo, Japan

Higashimurayama, Tokyo, Japan

Higashiyamato, Tokyo, Japan

Hino, Tokyo, Japan

Inagi, Tokyo, Japan

Katsushika-ku, Tokyo, Japan

Kita-ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Koganei, Tokyo, Japan

Koto, Tokyo, Japan

Machida, Tokyo, Japan

Meguro City, Tokyo, Japan

Minato, Tokyo, Japan

Mitaka, Tokyo, Japan

Nakano City, Tokyo, Japan

Nerima City, Tokyo, Japan

Nishitōkyō, Tokyo, Japan

Ōme, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya City, Tokyo, Japan

Shibuya City, Tokyo, Japan

Shinagawa, Tokyo, Japan

Shinjuku, Tokyo, Japan

Suginami, Tokyo, Japan

Sumida City, Tokyo, Japan

tabashi City, Tokyo, Japan

Tachikawa, Tokyo, Japan

Toshima City, Tokyo, Japan

Kurayoshi, Tottori, Japan

Sakaiminato, Tottori, Japan

Imizu, Toyama, Japan

Kurobe-shi, Toyama, Japan

Nakaniikawa, Toyama, Japan

Namerikawa, Toyama, Japan

Nanto, Toyama, Japan

Takaoka, Toyama, Japan

Tonami, Toyama, Japan

Gobō, Wakayama, Japan

Higashimuro, Wakayama, Japan

Iwade, Wakayama, Japan

Kainan, Wakayama, Japan

Nishimuro, Wakayama, Japan

Tanabe, Wakayama, Japan

Higashiokitama, Yamagata, Japan

Kaminoyama, Yamagata, Japan

Sakata, Yamagata, Japan

Hagi, Yamaguchi, Japan

Hikari, Yamaguchi, Japan

Iwakuni, Yamaguchi, Japan

Sanyōonoda, Yamaguchi, Japan

Shimonoseki, Yamaguchi, Japan

Ube, Yamaguchi, Japan

Yanai, Yamaguchi, Japan

Chūō, Yamanashi, Japan

Fuefuki, Yamanashi, Japan

Kofu, Yamanashi, Japan

Kōshū, Yamanashi, Japan

Minami-Alps, Yamanashi, Japan

Minamikoma, Yamanashi, Japan

Tsuru, Yamanashi, Japan

Aichi, , Japan

Akita, , Japan

Aomori, , Japan

Chiba, , Japan

Fukui, , Japan

Fukuoka, , Japan

Fukushima, , Japan

Gifu, , Japan

Hiroshima, , Japan

Kagoshima, , Japan

Kochi, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Mie, , Japan

Miyazaki, , Japan

Nagano, , Japan

Nagasaki, , Japan

Nara, , Japan

Niigata, , Japan

Okayama, , Japan

Osaka, , Japan

Ōita, , Japan

Saga, , Japan

Saitama, , Japan

Shizuoka, , Japan

Tochigi, , Japan

Tokushima, , Japan

Tottori, , Japan

Toyama, , Japan

Wakayama, , Japan

Yamagata, , Japan

Yamanashi, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 28502925 (View on PubMed)

Other Identifiers

PRT11T

Identifier Type: -

Identifier Source: org_study_id