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

This study is currently recruiting participants.
Verified October 2012 by Ono Pharmaceutical Co. Ltd
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01707901
First received: October 10, 2012
Last updated: April 14, 2014
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
GERD
Drug: ONO-8539
Other: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Daily, through a pain assessment score chart


Secondary Outcome Measures:
  • To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Daily, by observation

  • To assess the tolerability of ONO-8539 [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Daily, through observation

  • To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Daily, through observation and a pain score chart

  • To evaluate the effect of ONO-8539 on quality of life [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Daily, through Quality of life assessment questionnaires

  • To investigate the pharmacokinetics of ONO-8539 [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

    AUC, Cmax, Tmax

    Concentrations of ONO-8539


  • To investigate the association among the changes in pharmacodynamics of ONO-8539 [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Correlation between pharmacokinetic results and study specific procedure results

  • To evaluate the use of antacid in each treatment group [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Daily record of frequency of use

  • To assess the safety of ONO-8539 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • To investigate the association among the changes in psychological parameters of ONO-8539 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Psychological parameters


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ONO-8539
ONO-8539
Drug: ONO-8539
Treatment
Other Name: Experimental
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707901

Contacts
Contact: Ono Pharma UK Ltd +44 (0)2074214920
Contact: Study Director

Locations
Belgium
Leuven Clinical site Recruiting
Leuven, Belgium, B-3000
United Kingdom
London Clinical site Recruiting
London, United Kingdom, E1 2AJ
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Study Director Clinical Department, Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01707901     History of Changes
Other Study ID Numbers: ONO-8539POE011
Study First Received: October 10, 2012
Last Updated: April 14, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Hypersensitivity
Gastroesophageal Reflux
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014