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

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ClinicalTrials.gov Identifier: NCT01707901
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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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

Condition or disease Intervention/treatment Phase
GERD Drug: ONO-8539 Other: Placebo Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : December 2012
Actual Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: ONO-8539
ONO-8539
 Drug: ONO-8539
Treatment
Other Name: Experimental
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD [ Time Frame: 28 Days ]
    Daily, by observation

  2. To assess the tolerability of ONO-8539 [ Time Frame: 28 Days ]
    Daily, through observation

  3. 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

  4. To evaluate the effect of ONO-8539 on quality of life [ Time Frame: 28 Days ]
    Daily, through Quality of life assessment questionnaires

  5. To investigate the pharmacokinetics of ONO-8539 [ Time Frame: 28 Days ]

    AUC, Cmax, Tmax

    Concentrations of ONO-8539


  6. 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

  7. 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

  8. To evaluate the use of antacid in each treatment group [ Time Frame: 28 Days ]
    Daily record of frequency of use

  9. To assess the safety of ONO-8539 [ Time Frame: 28 days ]
  10. To investigate the association among the changes in psychological parameters of ONO-8539 [ Time Frame: 28 days ]
    Psychological parameters


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707901


Locations
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Belgium
Leuven Clinical site
Leuven, Belgium, B-3000
United Kingdom
London Clinical site
London, United Kingdom, E1 2AJ
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Study Director Clinical Department, Ono Pharmaceutical Co. Ltd
More Information
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01707901    
Other Study ID Numbers: ONO-8539POE011
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Ono Pharmaceutical Co. Ltd:
GERD
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases