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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01321567
First received: March 18, 2011
Last updated: December 28, 2012
Last verified: December 2012
  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 Phase
Refractory Reflux Esophagitis
Drug: rabeprazole sodium
Phase 4

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with improvement in symptoms of GERD [ Time Frame: Check at predose, 4, 8, 16 and 32 weeks ] [ Designated as safety issue: No ]
  • Endoscopic healing rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Every 4-8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 3750
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Drug: 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321567

  Show 448 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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01321567     History of Changes
Other Study ID Numbers: PRT11T
Study First Received: March 18, 2011
Last Updated: December 28, 2012
Health Authority: Japan:Health, Labour and Welfare Ministry

Keywords provided by Eisai Inc.:
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
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014