Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer

Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer - Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015601

Enrollment

Registered

2014-11-07

Start date

2014-11-07

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

ONO-8539 450mg after breakfast, wash out over 1 week, placebo after breakfast placebo after breakfast, wash out over 1 week, ONO-8539 450mg after breakfast

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy adults 2. Subjects who don't have a trouble with the insertion of a transnasal endoscope at screening or within 3 months before this study 3. Subjects with written informed consent 4. non-smoker

Exclusion criteria

Exclusion criteria: 1. Subjects who take drugs except for nasal spray within 1 week befor intervention 2. Subjects whose basal LES pressure is less than 5mmHg at HRM 3. Subjects who drink alcohol or take nicotine within 24 hours before intervention 4. Subjects who are enrolled in other clinical trials within 3 months before this study 5. Past history of GI tract surgery except for endoscopic treatment 6. Any liver, kidney, or heart diseases 7. Subjects who are not eligible for participation judged by a doctor

Design outcomes

Primary

Measure	Time frame
The number of TLESRs	—

Countries

Japan

Contacts

Public ContactAkinari Sawada

Osaka City University Graduate School of Medicine Deaprtment of Gastroenterology

m1164972@med.osaka-cu.ac.jp06-6645-3811

Outcome results

None listed

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