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NCT01707901 Clinical Trial

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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01707901
Other study ID # ONO-8539POE011
Secondary ID
Status Completed
Phase Phase 1
First received October 10, 2012
Last updated October 13, 2015
Start date December 2012

Study information
Verified date October 2015
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-8539
Treatment
Other:
• Placebo
Placebo

Locations
Country Name City State
Belgium Leuven Clinical site Leuven
United Kingdom London Clinical site London

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion Daily, through a pain assessment score chart 28 Days No
Secondary To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD Daily, by observation 28 Days No
Secondary To assess the tolerability of ONO-8539 Daily, through observation 28 Days Yes
Secondary To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation Daily, through observation and a pain score chart 28 Days No
Secondary To evaluate the effect of ONO-8539 on quality of life Daily, through Quality of life assessment questionnaires 28 Days No
Secondary To investigate the pharmacokinetics of ONO-8539 AUC, Cmax, Tmax
Concentrations of ONO-8539		 28 Days No
Secondary To investigate the association among the changes in pharmacodynamics of ONO-8539 Daily observation and through Quality of life assessment questionnaires 28 Days No
Secondary 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 No
Secondary To evaluate the use of antacid in each treatment group Daily record of frequency of use 28 Days No
Secondary To assess the safety of ONO-8539 28 days Yes
Secondary To investigate the association among the changes in psychological parameters of ONO-8539 Psychological parameters 28 days No
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