Back to resultsA Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Primary Purpose
GERD
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ONO-8539
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring GERD
Eligibility Criteria
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.
Sites / Locations
- Leuven Clinical site
- London Clinical site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ONO-8539
Placebo
Arm Description
ONO-8539
Placebo
Outcomes
Primary Outcome Measures
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
Daily, through a pain assessment score chart
Secondary Outcome Measures
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
Daily, by observation
To assess the tolerability of ONO-8539
Daily, through observation
To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
Daily, through observation and a pain score chart
To evaluate the effect of ONO-8539 on quality of life
Daily, through Quality of life assessment questionnaires
To investigate the pharmacokinetics of ONO-8539
AUC, Cmax, Tmax
Concentrations of ONO-8539
To investigate the association among the changes in pharmacodynamics of ONO-8539
Daily observation and through Quality of life assessment questionnaires
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
To evaluate the use of antacid in each treatment group
Daily record of frequency of use
To assess the safety of ONO-8539
To investigate the association among the changes in psychological parameters of ONO-8539
Psychological parameters
Full Information
NCT ID
NCT01707901
First Posted
October 10, 2012
Last Updated
October 13, 2015
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01707901
Brief Title
A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Official Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ONO-8539
Arm Type
Experimental
Arm Description
ONO-8539
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ONO-8539
Other Intervention Name(s)
Experimental
Intervention Description
Treatment
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
Description
Daily, through a pain assessment score chart
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
Description
Daily, by observation
Time Frame
28 Days
Title
To assess the tolerability of ONO-8539
Description
Daily, through observation
Time Frame
28 Days
Title
To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
Description
Daily, through observation and a pain score chart
Time Frame
28 Days
Title
To evaluate the effect of ONO-8539 on quality of life
Description
Daily, through Quality of life assessment questionnaires
Time Frame
28 Days
Title
To investigate the pharmacokinetics of ONO-8539
Description
AUC, Cmax, Tmax
Concentrations of ONO-8539
Time Frame
28 Days
Title
To investigate the association among the changes in pharmacodynamics of ONO-8539
Description
Daily observation and through Quality of life assessment questionnaires
Time Frame
28 Days
Title
To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539
Description
Correlation between pharmacokinetic results and study specific procedure results
Time Frame
28 Days
Title
To evaluate the use of antacid in each treatment group
Description
Daily record of frequency of use
Time Frame
28 Days
Title
To assess the safety of ONO-8539
Time Frame
28 days
Title
To investigate the association among the changes in psychological parameters of ONO-8539
Description
Psychological parameters
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Clinical Department, Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Leuven Clinical site
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
London Clinical site
City
London
ZIP/Postal Code
E1 2AJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
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