Acid Reflux Clinical Trial
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
NCT number | NCT01705275 |
Other study ID # | ONO-8539POE012 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | August 3, 2012 |
Last updated | July 4, 2014 |
Start date | January 2013 |
A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | London Clinical site Recruiting | London |
Lead Sponsor | Collaborator |
---|---|
Ono Pharmaceutical Co. Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion. | 15 days | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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. | 15 Days | No | |
Secondary | Safety and tolerability: adverse events, physical examination, body weight, vital signs, 12-lead Electrocardiogram (ECG) and safety laboratory evaluations. | 15 Days | Yes | |
Secondary | 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. | 15 Days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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