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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acid Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ONO-8539 BID

ONO-8539

Group Type EXPERIMENTAL

ONO-8539

Intervention Type DRUG

ONO-8539

Placebo BID

0mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Identical to ONO-8539 tablet but without active ingedient

Interventions

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ONO-8539

Intervention Type DRUG

Placebo

Identical to ONO-8539 tablet but without active ingedient

Intervention Type OTHER

Other Intervention Names

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ONO-8539 acid hypersensitivity 0mg ONO-8539

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes