CompletedNCT01321567Updated Jul 24, 2023

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

An observational study in Refractory Reflux Esophagitis, sponsored by Eisai Co., Ltd.. Completed at 447 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Eisai Co., Ltd. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 2,157
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Refractory Reflux Esophagitis

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Keywords

rabeprazole sodium
refractory reflux esophagitis

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 2,157 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Hospitals and Clinics in Japan

Inclusion criteria

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

Exclusion criteria

Exclusion criteria;

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2,157 participants (actual)

Groups and cohorts

Rabeprazole Sodium
Drug: rabeprazole sodium

Interventions

Drugrabeprazole 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 researchers measure

Primary outcomes

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

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

Study locations

447 sites

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
Daisen, Akita, Japan
Yokote, Akita, Japan
Yurihonjo, 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, 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
Ozu, Ehime, Japan
Saijo, Ehime, Japan
Uwajima, Ehime, Japan
Mikatakaminaka, Fukui, Japan
Ono, Fukui, Japan
Sabae, Fukui, Japan
Sakai, Fukui, Japan
Asakura, Fukuoka, Japan
Buzen, Fukuoka, Japan
Chikujo, Fukuoka, Japan
Chikushino, Fukuoka, Japan
Chikushi, 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
Iwaki, Fukushima, Japan
Koriyama, Fukushima, Japan
Shirakawa, Fukushima, Japan
Soma, Fukushima, Japan
Yama, Fukushima, Japan
Hashima, Gifu, Japan
Kakamigahara, Gifu, Japan
Minokamo, Gifu, Japan
Mizunami, Gifu, Japan
Ogaki, Gifu, Japan
Seki, Gifu, Japan
Tajimi, Gifu, Japan
Takayama, Gifu, Japan
Agatsuma, Gumma, Japan
Kiryu, Gumma, Japan
Maebashi, Gumma, Japan
Midori, Gumma, Japan
Ota, Gumma, Japan
Takasaki, Gumma, 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

Showing the first 100 of 447 sites.

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01321567
Lead sponsor: Eisai Co., Ltd.
Responsible party: Sponsor
First posted: Mar 23, 2011
Start date: Jan 1, 2011
Primary completion: Mar 1, 2013
Completion: Aug 1, 2013
Last update: Jul 24, 2023

Study contacts

Yoshinori Furuhata

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

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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