A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707901

Enrollment

Registered

2012-10-16

Start date

2012-12-31

Completion date

Unknown

Last updated

2015-10-14

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

Conditions

GERD

Keywords

GERD

Brief summary

A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease

Detailed description

This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

Interventions

DRUGONO-8539

Treatment

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate intensity heartburn while being on a stable dose of proton pump inhibitor and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.

Exclusion criteria

* Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or manometric abnormality or a protocol-specified cardiovascular condition will not be enrolled.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion	28 Days	Daily, through a pain assessment score chart

Secondary

Measure	Time frame	Description
To assess the tolerability of ONO-8539	28 Days	Daily, through observation
To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation	28 Days	Daily, through observation and a pain score chart
To evaluate the effect of ONO-8539 on quality of life	28 Days	Daily, through Quality of life assessment questionnaires
To investigate the pharmacokinetics of ONO-8539	28 Days	AUC, Cmax, Tmax Concentrations of ONO-8539
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD	28 Days	Daily, by observation
To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539	28 Days	Correlation between pharmacokinetic results and study specific procedure results
To evaluate the use of antacid in each treatment group	28 Days	Daily record of frequency of use
To assess the safety of ONO-8539	28 days	—
To investigate the association among the changes in psychological parameters of ONO-8539	28 days	Psychological parameters
To investigate the association among the changes in pharmacodynamics of ONO-8539	28 Days	Daily observation and through Quality of life assessment questionnaires

Countries

Belgium, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026