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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009124
Enrollment
80
Registered
2012-11-01
Start date
2012-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis outpatients with GERD symptom according to the GOS questionnaire

Interventions

Administration of 20mg/day Esomeprazole for 4 weeks

Sponsors

Department of Nephrology and Hypertension, Kawasaki Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Outpatients with thrice-per-week hemodialysis in which it takes more than 3 hours each 2) Patients with GERD symptom according to the GOS questionnaire 3) Patients with the informed consent to this study

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTamehachi Namikoshi

Kawasaki Medical School Department of Nephrology and Hypertension

tnamikoshi@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026