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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321567
First Posted: March 23, 2011
Last Update Posted: May 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
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. ( Eisai Co., Ltd. ):

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.

  Eligibility

Information from the National Library of Medicine

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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
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321567


  Show 447 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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.
ClinicalTrials.gov Identifier: NCT01321567     History of Changes
Other Study ID Numbers: PRT11T
First Submitted: March 18, 2011
First Posted: March 23, 2011
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
rabeprazole sodium
refractory reflux esophagitis

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action