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

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

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Key information

Conditions

Refractory Reflux Esophagitis Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aisai, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RABEPRAZOLE SODIUM

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.

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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 23, 2011
Registry last updated: Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed