A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers
A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Acid-induced Oesophageal Hypersensitivity in Healthy Male Adult Volunteers
1 other identifier
interventional
20
1 country
1
Brief Summary
A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedJuly 8, 2014
October 1, 2012
1.2 years
August 3, 2012
July 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve (AUC) of the change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
15 days
Secondary Outcomes (8)
Area under the Curve (AUC) of the change from baseline in pain threshold in the distal oesophagus following electrical stimulation after oesophageal acid infusion
15 days
Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion.
15 days
Change in absolute pain threshold from baseline in the proximal and distal oesophagus and somatic control following electrical stimulation after oesophageal acid infusion at each time point.
15 Days
Change from baseline at each time point in subject reported pain following electrical stimulation after oesophageal acid infusion using the short-form McGill pain questionnaire (SF-MPQ).
15 Days
Relationship between the pharmacokinetics of ONO-8539 and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
15 Days
- +3 more secondary outcomes
Study Arms (2)
ONO-8539 BID
EXPERIMENTALONO-8539
Placebo BID
PLACEBO COMPARATOR0mg
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Caucasian male subjects, aged 18-45 years inclusive, will be entered into this study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Clinical site Recruiting
London, London, E1 2AJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Clinical Department, Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
October 12, 2012
Study Start
January 1, 2013
Primary Completion
March 1, 2014
Last Updated
July 8, 2014
Record last verified: 2012-10