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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 10, 2012
First Posted Date  ICMJE October 16, 2012
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2012)		 To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion [ Time Frame: 30 Days ]
Daily, through a pain assment score chart
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD [ Time Frame: 28 Days ]
    Daily, by observation
  • To assess the tolerability of ONO-8539 [ Time Frame: 28 Days ]
    Daily, through observation
  • 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
  • To evaluate the effect of ONO-8539 on quality of life [ Time Frame: 28 Days ]
    Daily, through Quality of life assessment questionnaires
  • To investigate the pharmacokinetics of ONO-8539 [ Time Frame: 28 Days ]
    AUC, Cmax, Tmax Concentrations of ONO-8539
  • 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
  • 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
  • To evaluate the use of antacid in each treatment group [ Time Frame: 28 Days ]
    Daily record of frequency of use
  • To assess the safety of ONO-8539 [ Time Frame: 28 days ]
  • To investigate the association among the changes in psychological parameters of ONO-8539 [ Time Frame: 28 days ]
    Psychological parameters
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
  • To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD [ Time Frame: 30 Days ]
    Daily, by observation
  • To assess the tolerability of ONO-8539 [ Time Frame: 30 Days ]
    Daily, through observation and a pain score chart
  • To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation [ Time Frame: 30 Days ]
    Daily, through observation and a pain score chart
  • To evaluate the effect of ONO-8539 on quality of life [ Time Frame: 30 Days ]
    Daily, through Quality of life assessment questionnaires
  • To investigate the pharmacokinetics of ONO-8539 [ Time Frame: 30 Days ]
    AUC, Cmax, Tmax
  • To investigate the association among the changes in pharmacodynamics of ONO-8539 [ Time Frame: 30 Days ]
    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: 30 Days ]
    Correlation between pharmacokinetic results and study specific procedure results
  • To evaluate the use of antacid in each treatment group [ Time Frame: 30 Days ]
    Daily record of frequency of use
  • To assess the safety of ONO-8539 [ Time Frame: 30 days ]
  • To investigate the association among the changes in psychological parameters of ONO-8539 [ Time Frame: 30 days ]
    Quality of life assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE GERD
Intervention  ICMJE
  • Drug: ONO-8539
    Treatment
    Other Name: Experimental
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: ONO-8539
    ONO-8539
    Intervention: Drug: ONO-8539
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)		 14
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2012)		 30
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01707901
Other Study ID Numbers  ICMJE ONO-8539POE011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Clinical Department, Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP