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A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01705275
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Brief Summary:
A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers.

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

Detailed Description:
This is a randomised, double-blind, placebo-controlled, two-period crossover study, to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers. Each subject will be randomised to ONO-8539 or placebo twice daily in the first treatment period and the alternate treatment in the second treatment period. Dosing in each period will be for 15 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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 Acid-induced Oesophageal Hypersensitivity in Healthy Male Adult Volunteers
Study Start Date : January 2013
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: ONO-8539 BID
ONO-8539
Drug: ONO-8539
ONO-8539
Other Name: ONO-8539 acid hypersensitivity

Placebo Comparator: Placebo BID
0mg
Other: Placebo
Identical to ONO-8539 tablet but without active ingedient
Other Name: 0mg ONO-8539




Primary Outcome Measures :
  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. [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Area under the Curve (AUC) of the change from baseline in pain threshold in the distal oesophagus following electrical stimulation after oesophageal acid infusion [ Time Frame: 15 days ]
  2. Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion. [ Time Frame: 15 days ]
  3. 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. [ Time Frame: 15 Days ]
  4. 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). [ Time Frame: 15 Days ]
  5. 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. [ Time Frame: 15 Days ]
  6. Relationship between State Trait Anxiety Inventory (STAI)-state score and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion. [ Time Frame: 15 Days ]
  7. Safety and tolerability: adverse events, physical examination, body weight, vital signs, 12-lead Electrocardiogram (ECG) and safety laboratory evaluations. [ Time Frame: 15 Days ]
  8. The maximum observed plasma concentrations (Cmax), time to reach Cmax (Tmax), area under the curve (AUC), and trough concentration of ONO-8539 prior to dosing. [ Time Frame: 15 Days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Caucasian male subjects, aged 18-45 years inclusive, will be entered into this study.

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.

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): NCT01705275


Locations
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United Kingdom
London Clinical site Recruiting
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

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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01705275     History of Changes
Other Study ID Numbers: ONO-8539POE012
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: October 2012
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases