Effect of Esomeprazole on quality of life in hemodialysis patients with Gastroesophageal reflux disease (GERD) symptom

Not Applicable

• Conditions: Hemodialysis outpatients with GERD symptom according to the GOS questionnaire

• Registration Number: JPRN-UMIN000009124
• Lead Sponsor: Department of Nephrology and Hypertension, Kawasaki Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-01
• Study Completion: 2014-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with severe hepatic dysfunction (showing more than 100 IU/L of AST or ALT) 2) Patients with severe cardiac dysfunction 3) Patients receiving treatment for a malignant neoplasm 4) Patinets with HIV infection or receiving treatment for AIDS 5) Patients with the past history of vagotomy 6) Patients with the past history of the resection of upper digestive tract 7) Patients taking a contraindication drug for coadministration of Esomeprazole 8) Patients with current or past hypersensitivity to Esomeprazole or the similar drugs such as proton pump inhibitors (PPI) 9) Patients for whom it is difficult to fill out the questionnaires by themselves 10) Female in current or expected pregnancy 11) Female in breast-feeding 12) Patients judged as unsuitable for participating in this study by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of QOL according to the QOLRAD-J questionnaire after the administration of 20mg/day Esomeprazole for 4 weeks

Secondary Outcome Measures

Name	Time	Method
1) The proportion of upper abdominal symptom according to the GOS questionnaire in hemodialysis patients 2) The change of GERD symptom according to the GOS questionnaire after the administration of 20mg/day Esomeprazole for 4 weeks 3) The correlation between the scores of GOS and QOLRAD-J questionnaires before and 4 weeks after the intervention 4) The decrease on QOL in hemodialysis patients with GERD symptom compared with those without GERD symptom before the intervention 5) The rate of the detrimental events caused by the intervention drug