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

October 10, 2012
April 14, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
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
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Daily, through a pain assment score chart
Complete list of historical versions of study NCT01707901 on ClinicalTrials.gov Archive Site
  • 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
  • To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Daily, by observation
  • To assess the tolerability of ONO-8539 [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Daily, through observation and a pain score chart
  • To evaluate the effect of ONO-8539 on quality of life [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Daily, through Quality of life assessment questionnaires
  • To investigate the pharmacokinetics of ONO-8539 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    AUC, Cmax, Tmax
  • To investigate the association among the changes in pharmacodynamics of ONO-8539 [ Time Frame: 30 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: 30 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: 30 Days ] [ Designated as safety issue: No ]
    Daily record of frequency of use
  • To assess the safety of ONO-8539 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • To investigate the association among the changes in psychological parameters of ONO-8539 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Quality of life assessment
Not Provided
Not Provided
 
A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
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

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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
GERD
  • Drug: ONO-8539
    Treatment
    Other Name: Experimental
  • Other: Placebo
    Placebo
  • Experimental: ONO-8539
    ONO-8539
    Intervention: Drug: ONO-8539
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Ono Pharma UK Ltd +44 (0)2074214920
Contact: Study Director
Belgium,   United Kingdom
 
NCT01707901
ONO-8539POE011
No
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Study Director Clinical Department, Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
October 2012

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