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

Phase 1

Completed

• Conditions: GERD
• Interventions: Other: Placebo; Drug: ONO-8539

• Registration Number: NCT01707901
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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

Study Timeline

• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2012-12
• Primary Completion: 2014-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
ONO-8539	ONO-8539	ONO-8539

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD	28 Days	Daily, by observation
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 investigate the association among the changes in pharmacodynamics of ONO-8539	28 Days	Daily observation and through Quality of life assessment questionnaires
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 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

Trial Locations

Locations (2)

London Clinical site; 🇬🇧 London, United Kingdom

Leuven Clinical site; 🇧🇪 Leuven, Belgium