ONO-8539 Acid Sensitisation Study

• Research type

  Research Study

• Full 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.

• IRAS ID

  111472

• Contact name

  Qasim Aziz

• Sponsor organisation

  ONO Pharmaceutical Co., Ltd

• Eudract number

  2012-000461-20

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The aim of the study is to assess the effects of the study compound on pain levels in the oesophagus. Also the aims are to assess the safety of the compound and how it effects the number of time the patient suffers the symptoms, the quality of the patients lives, how the compound moves through the body, how it is removed from the body, how much antacid the patients need to use. These will all be determined using collection of adverse events, questionnaires, and blood and urine tests. Twenty subjects will be recruited and they will either receive placebo for 15 days then ONO-8539 for 15 days, or they will receive ONO-8539 and then placebo after. Between the two treatment phases there will be a wash out period of at least 13 days. All subject will be male, Caucasian and between 18-45 years of age.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0358

• Date of REC Opinion

  5 Oct 2012

• REC opinion

  Further Information Favourable Opinion