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A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease

A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease - A study to evaluate the effect of Proton pump inhibitor on sleep dysfunction in patients with Gastroesophageal reflex disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011797
Enrollment
70
Registered
2013-09-20
Start date
2012-05-17
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

Gastroesophageal reflux disease

Interventions

10 mg of sodium rabeprazole administered orally once daily from 2 to 4 weeks

Sponsors

Heiwadai clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A patient is eligible for the study if all of the following criteria are met: 1) Age 20 years or older 2) Patients with more than 8 scores in the Frequency scale for Symptoms of GERD (F-scale questionnaires) 3) Patient with at least 2 weeks washout period from the previous treatment by Proton pump inhibitors and Histamine H2-receptor antagonists

Exclusion criteria

Exclusion criteria: A patient is excluded from the study if any of the following criteria are met: 1) Patients with a history of hypersensitivity to any ingredients of sodium rabeprazole 2) Patients taking atazanavir sulfate or rilpivirine hydrochloride 3) Patients with serious hepatic function disorder 4) Elderly patients (Age 80 years and older) 5) Patients who were judged to be inappropriate for participation in this study by the investigator

Design outcomes

Primary

MeasureTime frame
1)Change rate of average numerical rating scale (NRS) of sleep quality between a pre-dose and a post-dose of 2-4 weeks after administration 2)Fluctuation of scores in sleep dysfunction questionnaires between a pre-dose and a post-dose of 2-4 weeks after administration

Secondary

MeasureTime frame
Fluctuation of scores in F-scale questionnaires between a pre-dose and a post-dose of 2-4 weeks after administration

Countries

Japan

Contacts

Public ContactMotoyasu chibai

Heiwadai clinic Surgery

bk2m-cbi@asahi-net.or.jp03-5922-1241

Outcome results

None listed

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