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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014