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

Ono Pharmaceutical Co., Ltd.14 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

GERD

Interventions

ONO-8539DRUG

Treatment

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

Leuven Clinical site

Leuven, Leuven, Belgium

London Clinical site

London, London, United Kingdom

Outcomes

Primary Outcomes

To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion

Daily, through a pain assessment score chart

Time frame: 28 Days

Secondary Outcomes

To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD

Daily, by observation

Time frame: 28 Days

To assess the tolerability of ONO-8539

Daily, through observation

Time frame: 28 Days

To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation

Daily, through observation and a pain score chart

Time frame: 28 Days

To evaluate the effect of ONO-8539 on quality of life

Daily, through Quality of life assessment questionnaires

Time frame: 28 Days

To investigate the pharmacokinetics of ONO-8539

AUC, Cmax, Tmax Concentrations of ONO-8539

Time frame: 28 Days

To investigate the association among the changes in pharmacodynamics of ONO-8539

Daily observation and through Quality of life assessment questionnaires

Time frame: 28 Days

To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539

Correlation between pharmacokinetic results and study specific procedure results

Data from ClinicalTrials.gov

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