Clinical trial NCT01707901: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Keywords: GERD
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
timeFrame: 28 Days
Secondary outcomes:
measure: To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
timeFrame: 28 Days
measure: To assess the tolerability of ONO-8539
timeFrame: 28 Days
measure: To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
timeFrame: 28 Days
measure: To evaluate the effect of ONO-8539 on quality of life
timeFrame: 28 Days
measure: To investigate the pharmacokinetics of ONO-8539
timeFrame: 28 Days
measure: To investigate the association among the changes in pharmacodynamics of ONO-8539
timeFrame: 28 Days
measure: To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539
timeFrame: 28 Days
measure: To evaluate the use of antacid in each treatment group
timeFrame: 28 Days
measure: To assess the safety of ONO-8539
timeFrame: 28 days
measure: To investigate the association among the changes in psychological parameters of ONO-8539
timeFrame: 28 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven Clinical site
city: London
country: United Kingdom
facility: London Clinical site
Study officials:
affiliation: Clinical Department, Ono Pharmaceutical Co. Ltd
name: Study Director
role: STUDY_DIRECTOR
References: