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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Drug: ONO-8539
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-8539<br>ONO-8539 | Drug: ONO-8539<br>* Treatment<br>* Other names: Experimental;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD