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

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Other: Placebo; Drug: ONO-8539

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • Leuven Clinical site
• United Kingdom
  • London, United Kingdom, E1 2AJ
    • London Clinical site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: ONO-8539	Drug: ONO-8539; Treatment; Other Names: Experimental

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Study Director, Clinical Department, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: GERD
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: ONO-8539POE011