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Completed

NCT Number: NCT01705275

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

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

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Key information

Conditions

Acid Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

London Clinical site Recruiting

London, E1 2AJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ONO-8539

Drug

ONO-8539

Other names: ONO-8539 acid hypersensitivity

Placebo

Other

Identical to ONO-8539 tablet but without active ingedient

Other names: 0mg ONO-8539

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.

    Time frame: 15 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
First posted
Oct 12, 2012
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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