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

July 21, 2023 updated by: Eisai Co., Ltd.
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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
      • Oita, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Saga, Japan
      • Saitama, Japan
      • Shizuoka, Japan
      • Tochigi, Japan
      • Tokushima, Japan
      • Tottori, Japan
      • Toyama, Japan
      • Wakayama, Japan
      • Yamagata, Japan
      • Yamanashi, Japan
    • Aichi
      • Aisai, Aichi, Japan
      • Anjo, Aichi, Japan
      • Gamagori, Aichi, Japan
      • Ichinomiya, Aichi, Japan
      • Inuyama, Aichi, Japan
      • Kariya, Aichi, Japan
      • Kasugai, Aichi, Japan
      • Nagoya, Aichi, Japan
      • Okazaki, Aichi, Japan
      • Owariasahi, Aichi, Japan
      • Tokai, Aichi, Japan
      • Tokoname, Aichi, Japan
      • Toyota, Aichi, Japan
      • Tsushima, Aichi, Japan
    • Akita
      • Daisen, Akita, Japan
      • Yokote, Akita, Japan
      • Yurihonjo, Akita, Japan
    • Aomori
      • Goshogawara, Aomori, Japan
      • Hachinohe, Aomori, Japan
      • Hirosaki, Aomori, Japan
      • Kitatsugaru, Aomori, Japan
      • Mutsu, Aomori, Japan
      • Sannohe, Aomori, Japan
      • Towada, Aomori, Japan
    • Chiba
      • Asahi, Chiba, Japan
      • Choshi, Chiba, Japan
      • Funabashi, Chiba, Japan
      • Ichihara, Chiba, Japan
      • Ichikawa, Chiba, Japan
      • Kashiwa, Chiba, Japan
      • Katori, Chiba, Japan
      • Matsudo, Chiba, Japan
      • Mobara, Chiba, Japan
      • Narashino, Chiba, Japan
      • Noda, Chiba, Japan
    • Ehime
      • Imabari, Ehime, Japan
      • Kitauwa, Ehime, Japan
      • Matsuyama, Ehime, Japan
      • Niihama, Ehime, Japan
      • Ozu, Ehime, Japan
      • Saijo, Ehime, Japan
      • Uwajima, Ehime, Japan
    • Fukui
      • Mikatakaminaka, Fukui, Japan
      • Ono, Fukui, Japan
      • Sabae, Fukui, Japan
      • Sakai, Fukui, Japan
    • Fukuoka
      • Asakura, Fukuoka, Japan
      • Buzen, Fukuoka, Japan
      • Chikujo, Fukuoka, Japan
      • Chikushi, Fukuoka, Japan
      • Chikushino, Fukuoka, Japan
      • Kasuga, Fukuoka, Japan
      • Kasuya, Fukuoka, Japan
      • Kitakyushu, Fukuoka, Japan
      • Kurume, Fukuoka, Japan
      • Miyama, Fukuoka, Japan
      • Munakata, Fukuoka, Japan
      • Nogata, Fukuoka, Japan
      • Okawa, Fukuoka, Japan
      • Omuta, Fukuoka, Japan
      • Tagawa, Fukuoka, Japan
      • Yame, Fukuoka, Japan
    • Fukushima
      • Iwaki, Fukushima, Japan
      • Koriyama, Fukushima, Japan
      • Shirakawa, Fukushima, Japan
      • Soma, Fukushima, Japan
      • Yama, Fukushima, Japan
    • Gifu
      • Hashima, Gifu, Japan
      • Kakamigahara, Gifu, Japan
      • Minokamo, Gifu, Japan
      • Mizunami, Gifu, Japan
      • Ogaki, Gifu, Japan
      • Seki, Gifu, Japan
      • Tajimi, Gifu, Japan
      • Takayama, Gifu, Japan
    • Gumma
      • Agatsuma, Gumma, Japan
      • Kiryu, Gumma, Japan
      • Maebashi, Gumma, Japan
      • Midori, Gumma, Japan
      • Ota, Gumma, Japan
      • Takasaki, Gumma, Japan
    • Hiroshima
      • Aki, Hiroshima, Japan
      • Fukuyama, Hiroshima, Japan
      • Higashihiroshima, Hiroshima, Japan
      • Kure, Hiroshima, Japan
      • Mihara, Hiroshima, Japan
      • Miyoshi, Hiroshima, Japan
      • Onomichi, Hiroshima, Japan
      • Takehara, Hiroshima, Japan
    • Hokkaido
      • 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
    • Hyogo
      • Aioi, Hyogo, Japan
      • Akashi, Hyogo, Japan
      • Ako, Hyogo, Japan
      • Amagasaki, Hyogo, Japan
      • Ashiya, Hyogo, Japan
      • Awaji, Hyogo, Japan
      • Himeji, Hyogo, Japan
      • Itami, Hyogo, Japan
      • Kakogawa, Hyogo, Japan
      • Kobe, Hyogo, Japan
      • Miki, Hyogo, Japan
      • Nishinomiya, Hyogo, Japan
      • Ono, Hyogo, Japan
      • Sanda, Hyogo, Japan
      • Sasayama, Hyogo, Japan
      • Sumoto, Hyogo, Japan
      • Takarazuka, Hyogo, Japan
      • Tamba, Hyogo, Japan
    • Ibaraki
      • Bando, Ibaraki, Japan
      • Hitachi, Ibaraki, Japan
      • Hitachiota, Ibaraki, Japan
      • Hokota, Ibaraki, Japan
      • Ishioka, Ibaraki, Japan
      • Itako, Ibaraki, Japan
      • Joso, Ibaraki, Japan
      • Kitaibaraki, Ibaraki, Japan
      • Koga, Ibaraki, Japan
      • Mito, Ibaraki, Japan
      • Moriya, Ibaraki, Japan
      • Naka, Ibaraki, Japan
      • Ryugasaki, Ibaraki, Japan
      • Shimotsuma, Ibaraki, Japan
      • Tsukuba, Ibaraki, Japan
      • Ushiku, Ibaraki, Japan
    • Ishikawa
      • Hakui, Ishikawa, Japan
      • Hakusan, Ishikawa, Japan
      • Kahoku, Ishikawa, Japan
      • Kanazawa, Ishikawa, Japan
      • Nomi, Ishikawa, Japan
    • Iwate
      • Hanamaki, Iwate, Japan
      • Ichinoseki, Iwate, Japan
      • Morioka, Iwate, Japan
      • Oshu, Iwate, Japan
      • Tono, Iwate, Japan
    • Kagawa
      • Kanonji, Kagawa, Japan
      • Marugame, Kagawa, Japan
      • Mitoyo, Kagawa, Japan
      • Takamatsu, Kagawa, Japan
    • Kagoshima
      • Aira, Kagoshima, Japan
      • Ichikikushikino, Kagoshima, Japan
      • Isa, Kagoshima, Japan
      • Izumi, Kagoshima, Japan
      • Kanoya, Kagoshima, Japan
      • Kirishima, Kagoshima, Japan
      • Kumage, Kagoshima, Japan
      • Satsumasendai, Kagoshima, Japan
    • Kanagawa
      • 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
    • Kumamoto
      • Aso, Kumamoto, Japan
      • Hitoyoshi, Kumamoto, Japan
      • Kamimashiki, Kumamoto, Japan
      • Koshi, Kumamoto, Japan
      • Kuma, Kumamoto, Japan
      • Yatsushiro, Kumamoto, Japan
    • Kyoto
      • Fukuchiyama, Kyoto, Japan
      • Kameoka, Kyoto, Japan
      • Kyotango, Kyoto, Japan
      • Maizuru, Kyoto, Japan
      • Muko, Kyoto, Japan
      • Nantan, Kyoto, Japan
      • Yosa, Kyoto, Japan
    • Mie
      • Iga, Mie, Japan
      • Ise, Mie, Japan
      • Kameyama, Mie, Japan
      • Kitamuro, Mie, Japan
      • Kuwana, Mie, Japan
      • Matsusaka, Mie, Japan
      • Suzuka, Mie, Japan
      • Tsu, Mie, Japan
      • Yokkaichi, Mie, Japan
    • Miyagi
      • Osaki, Miyagi, Japan
      • Sendai, Miyagi, Japan
      • Shiroishi, Miyagi, Japan
      • Toda, Miyagi, Japan
      • Tome, Miyagi, Japan
    • Miyazaki
      • Ebino, Miyazaki, Japan
      • Hyuga, Miyazaki, Japan
      • Koyu, Miyazaki, Japan
      • Kushima, Miyazaki, Japan
      • Miyakonojo, Miyazaki, Japan
      • Nobeoka, Miyazaki, Japan
    • Nagano
      • Ina, Nagano, Japan
      • Kamiina, Nagano, Japan
      • Kiso, Nagano, Japan
      • Komagane, Nagano, Japan
      • Matsumoto, Nagano, Japan
      • Nakano, Nagano, Japan
      • Saku, Nagano, Japan
      • Ueda, Nagano, Japan
    • Nagasaki
      • Isahaya, Nagasaki, Japan
      • Sasebo, Nagasaki, Japan
      • Unzen, Nagasaki, Japan
    • Nara
      • Gojo, Nara, Japan
      • Ikoma, Nara, Japan
      • Kashihara, Nara, Japan
      • Kitakatsuragi, Nara, Japan
      • Sakurai, Nara, Japan
      • Tenri, Nara, Japan
      • Uda, Nara, Japan
      • Yamatokoriyama, Nara, Japan
      • Yamatotakada, Nara, Japan
    • Niigata
      • Joetsu, Niigata, Japan
      • Kashiwazaki, Niigata, Japan
      • Minamiuonuma, Niigata, Japan
      • Mitsuke, Niigata, Japan
      • Nagaoka, Niigata, Japan
      • Sado, Niigata, Japan
      • Shibata, Niigata, Japan
      • Tokamachi, Niigata, Japan
    • Oita
      • Kunisaki, Oita, Japan
      • Nakatsu, Oita, Japan
      • Taketa, Oita, Japan
      • Usa, Oita, Japan
      • Yufu, Oita, Japan
    • Okayama
      • Akaiwa, Okayama, Japan
      • Asakuchi, Okayama, Japan
      • Bizen, Okayama, Japan
      • Kurashiki, Okayama, Japan
      • Niimi, Okayama, Japan
      • Tsukubo, Okayama, Japan
      • Tsuyama, Okayama, Japan
    • Okinawa
      • Itoman, Okinawa, Japan
      • Nago, Okinawa, Japan
      • Nakagami, Okinawa, Japan
      • Tomigusuku, Okinawa, Japan
      • Urasoe, Okinawa, Japan
    • Osaka
      • Daito, Osaka, Japan
      • Fujiidera, Osaka, Japan
      • Higashiosaka, Osaka, Japan
      • Hirakata, Osaka, Japan
      • Ibaraki, Osaka, Japan
      • Izumi, Osaka, Japan
      • Izumiotsu, 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
      • Osakasayama, Osaka, Japan
      • Sakai, 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
    • Saga
      • Imari, Saga, Japan
      • Kanzaki, Saga, Japan
      • Ogi, Saga, Japan
      • Takeo, Saga, Japan
      • Taku, Saga, Japan
      • Tosu, Saga, Japan
    • Saitama
      • Ageo, Saitama, Japan
      • Chichibu, Saitama, Japan
      • Fujimi, Saitama, Japan
      • Fukaya, Saitama, Japan
      • Hanno, Saitama, Japan
      • Hidaka, Saitama, Japan
      • Kasukabe, Saitama, Japan
      • Kawagoe, Saitama, Japan
      • Kawaguchi, Saitama, Japan
      • Kazo, Saitama, Japan
      • Kitaadachi, Saitama, Japan
      • Koshigaya, Saitama, Japan
      • Kuki, Saitama, Japan
      • Sayama, Saitama, Japan
      • Toda, Saitama, Japan
      • Tokorozawa, Saitama, Japan
      • Warabi, Saitama, Japan
    • Shiga
      • Koka, Shiga, Japan
      • Kusatsu, Shiga, Japan
      • Moriyama, Shiga, Japan
      • Nagahama, Shiga, Japan
      • Otsu, Shiga, Japan
      • Ritto, Shiga, Japan
    • Shimane
      • Izumo, Shimane, Japan
      • Matsue, Shimane, Japan
      • Yasugi, Shimane, Japan
    • Shizuoka
      • Fuji, Shizuoka, Japan
      • Fujieda, Shizuoka, Japan
      • Fujinomiya, Shizuoka, Japan
      • Fukuroi, Shizuoka, Japan
      • Hamamatsu, Shizuoka, Japan
      • Ito, 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
    • Tochigi
      • Moka, Tochigi, Japan
      • Nikko, Tochigi, Japan
      • Sano, Tochigi, Japan
      • Shimotsuga, Tochigi, Japan
      • Utsunomiya, Tochigi, Japan
    • Tokushima
      • Anan, Tokushima, Japan
      • Awa, Tokushima, Japan
      • Itano, Tokushima, Japan
      • Myozai, Tokushima, Japan
      • Naruto, Tokushima, Japan
    • Tokyo
      • Adachi, Tokyo, Japan
      • Akiruno, Tokyo, Japan
      • Akishima, Tokyo, Japan
      • Bunkyo, Tokyo, Japan
      • Chiyoda, Tokyo, Japan
      • Chuo, Tokyo, Japan
      • Edogawa, Tokyo, Japan
      • Fuchu, Tokyo, Japan
      • Hachioji, Tokyo, Japan
      • Higashimurayama, Tokyo, Japan
      • Higashiyamato, Tokyo, Japan
      • Hino, Tokyo, Japan
      • Inagi, Tokyo, Japan
      • Itabashi, Tokyo, Japan
      • Katsushika, Tokyo, Japan
      • Kita, Tokyo, Japan
      • Kodaira, Tokyo, Japan
      • Koganei, Tokyo, Japan
      • Koto, Tokyo, Japan
      • Machida, Tokyo, Japan
      • Meguro, Tokyo, Japan
      • Minato, Tokyo, Japan
      • Mitaka, Tokyo, Japan
      • Nakano, Tokyo, Japan
      • Nerima, Tokyo, Japan
      • Nishitokyo, Tokyo, Japan
      • Ome, Tokyo, Japan
      • Ota, Tokyo, Japan
      • Setagaya, Tokyo, Japan
      • Shibuya, Tokyo, Japan
      • Shinagawa, Tokyo, Japan
      • Shinjuku, Tokyo, Japan
      • Suginami, Tokyo, Japan
      • Sumida, Tokyo, Japan
      • Tachikawa, Tokyo, Japan
      • Toshima, Tokyo, Japan
    • Tottori
      • Kurayoshi, Tottori, Japan
      • Sakaiminato, Tottori, Japan
    • Toyama
      • Imizu, Toyama, Japan
      • Kurobe, Toyama, Japan
      • Nakaniikawa, Toyama, Japan
      • Namerikawa, Toyama, Japan
      • Nanto, Toyama, Japan
      • Takaoka, Toyama, Japan
      • Tonami, Toyama, Japan
    • Wakayama
      • Hidaka, Wakayama, Japan
      • Higashimuro, Wakayama, Japan
      • Iwade, Wakayama, Japan
      • Kainan, Wakayama, Japan
      • Nishimuro, Wakayama, Japan
      • Tanabe, Wakayama, Japan
    • Yamagata
      • Higashiokitama, Yamagata, Japan
      • Kaminoyama, Yamagata, Japan
      • Sakata, Yamagata, Japan
    • Yamaguchi
      • Hagi, Yamaguchi, Japan
      • Hikari, Yamaguchi, Japan
      • Iwakuni, Yamaguchi, Japan
      • SanyoOnoda, Yamaguchi, Japan
      • Shimonoseki, Yamaguchi, Japan
      • Ube, Yamaguchi, Japan
      • Yanai, Yamaguchi, Japan
    • Yamanashi
      • Chuo, Yamanashi, Japan
      • Fuefuki, Yamanashi, Japan
      • Kofu, Yamanashi, Japan
      • Koshu, Yamanashi, Japan
      • Minami-Alps, Yamanashi, Japan
      • Minamikoma, Yamanashi, Japan
      • Tsuru, Yamanashi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospitals and Clinics in Japan

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Check at predose, 4, 8, 16 and 32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with improvement in symptoms of GERD
Time Frame: Check at predose, 4, 8, 16 and 32 weeks
Check at predose, 4, 8, 16 and 32 weeks
Endoscopic healing rate
Time Frame: 8 weeks
8 weeks
Adverse events
Time Frame: Every 4-8 weeks
Every 4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Yoshinori Furuhata, Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimated)

March 23, 2011

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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