ONO-8539
DrugTreatment
Other names: Experimental
Completed
NCT Number: NCT01707901
A Study of 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
Completed
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Leuven Clinical site, Leuven, Belgium
Loading trial locations.
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
OtherPlacebo
Primary outcomes
-
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
Time frame: 28 Days
Daily, through a pain assessment score chart
Secondary outcomes
-
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
Time frame: 28 Days
Daily, by observation
-
To assess the tolerability of ONO-8539
Time frame: 28 Days
Daily, through observation
-
To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
Time frame: 28 Days
Daily, through observation and a pain score chart
-
To evaluate the effect of ONO-8539 on quality of life
Time frame: 28 Days
Daily, through Quality of life assessment questionnaires
-
To investigate the pharmacokinetics of ONO-8539
Time frame: 28 Days
AUC, Cmax, Tmax
Concentrations of ONO-8539
-
To investigate the association among the changes in pharmacodynamics of ONO-8539
Time frame: 28 Days
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
Time frame: 28 Days
Correlation between pharmacokinetic results and study specific procedure results
-
To evaluate the use of antacid in each treatment group
Time frame: 28 Days
Daily record of frequency of use
-
To assess the safety of ONO-8539
Time frame: 28 days
-
To investigate the association among the changes in psychological parameters of ONO-8539
Time frame: 28 days
Psychological parameters
Sponsors and collaborators
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2012
- Primary completion
- 2014
- First posted
- Oct 16, 2012
- Registry last updated
- Oct 14, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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