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

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. ) Identifier:
First received: March 18, 2011
Last updated: May 13, 2015
Last verified: May 2015
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis

Condition Intervention
Refractory Reflux Esophagitis
Drug: rabeprazole sodium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 2157
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rabeprazole Sodium Drug: 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   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;

  • Patients with a history of hypersensitivity to any ingredients of PARIET.
  • Patients on atazanavir sulfate.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01321567

  Show 447 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Yoshinori Furuhata Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd. Identifier: NCT01321567     History of Changes
Other Study ID Numbers: PRT11T
Study First Received: March 18, 2011
Last Updated: May 13, 2015

Keywords provided by Eisai Inc.:
rabeprazole sodium
refractory reflux esophagitis

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017